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Comparison of Coronary Risk Factors and Quality of Life in Coronary Artery Disease Patients With Versus Without Diabetes Mellitus

      It is unclear whether patients with coronary artery disease (CAD) and diabetes mellitus (DM) can make comprehensive lifestyle changes that produce similar changes in coronary risk factors and quality of life compared with patients with CAD and without DM. We examined medical characteristics, lifestyle, and quality of life by diabetic status and gender in the Multicenter Lifestyle Demonstration Project (MLDP), a study of 440 nonsmoking patients with CAD (347 men, 55 with DM; 15.9%; 93 women, 36 with DM; 38.7%). Patients met in groups to improve lifestyle (plant-based, low-fat diet; exercise; stress management) for 1 year. Follow-ups were conducted at 3 and 12 months. At baseline, body mass and systolic blood pressure were significantly higher among patients with DM. Men with DM had a worse medical history (e.g., hypertension, hyperlipidemia, and family history of CAD) than did those without DM. Patients with DM, especially women, reported poorer quality of life than did patients without DM. The 2 groups of patients were able to adhere to the recommended lifestyle, as demonstrated by significant improvements in weight (mean −5 kg), body fat, low-density lipoprotein cholesterol, exercise capacity, and quality of life. No significant changes in triglycerides and high-density lipoprotein cholesterol were noted. By the end of 12 months, improvements in glucose-lowering medications (i.e., discontinuation or a change from insulin to oral hypoglycemic agents) were noted for 19.8% (n = 18) of patients with DM. In conclusion, patients with CAD and DM are able to follow a comprehensive lifestyle change program and show similar improvements in coronary risk factors and quality of life as those without DM.
      This investigation examined whether patients with coronary artery disease (CAD) and diabetes mellitus (DM) are able to make more intensive changes in diet and lifestyle and show similar improvements in clinical risk factors and quality of life compared with patients with CAD and without DM. To address this question, we compared data from men and women with CAD and DM (predominantly type 2) with those without DM. All patients participated in the Multicenter Lifestyle Demonstration Project (MLDP),
      • Koertge J.
      • Weidner G.
      • Elliott-Eller M.
      • Scherwitz L.
      • Merritt-Worden T.A.
      • Marlin R.
      • Lipsenthal L.
      • Guarneri M.
      • Finkel R.
      • Saunders Jr, D.E.
      • et al.
      Improvement in medical risk factors and quality of life in women and men with coronary artery disease in the Multicenter Lifestyle Demonstration Project.
      • Ornish D.
      Avoiding revascularization with lifestyle changes the Multicenter Lifestyle Demonstration Project.
      a multicomponent lifestyle intervention that emphasizes exercise, diet, and stress management (which was found to be especially beneficial for patients with DM
      • Surwit R.S.
      • Schneider M.S.
      Role of stress in the etiology and treatment of diabetes mellitus.
      • Pischke C.
      • Marlin R.
      • Weidner G.
      • Ornish D.
      The role of lifestyle in secondary prevention of coronary heart disease in patients with type 2 diabetes.
      ).

      Methods

      Design, recruitment, and procedure of the MLDP

      The main aim of the MLDP was to examine whether patients can avoid revascularization by making comprehensive lifestyle changes without increasing cardiac events. Patients were classified into group 1 or group 2. Those in group 1 had angiographically documented CAD that was severe enough to warrant revascularization (by insurance coverage policy standards) at study entry but opted for lifestyle changes instead (deemed medically safe). Control group patients, who were matched to group 1 patients by procedure eligibility, age, gender, left ventricular ejection fraction, and cardiac score,
      • Ornish D.
      Avoiding revascularization with lifestyle changes the Multicenter Lifestyle Demonstration Project.
      were provided by Mutual of Omaha Insurance Company’s database (Omaha, Nebraska). Comparisons between the intervention and control groups indicated that 77% of the intervention group were able to avoid revascularization for ≥3 years by making comprehensive lifestyle changes without increasing cardiac events.
      • Ornish D.
      Avoiding revascularization with lifestyle changes the Multicenter Lifestyle Demonstration Project.
      Group 2 consisted of patients who had previous coronary artery bypass grafting or percutaneous transluminal coronary angioplasty, were in stable condition, and received the intervention. The focus of this study was on the intervention groups, as only events were monitored in the control group. The size of the intervention group allowed stratification by DM status. For more detail on the MLDP, see Koertge et al
      • Koertge J.
      • Weidner G.
      • Elliott-Eller M.
      • Scherwitz L.
      • Merritt-Worden T.A.
      • Marlin R.
      • Lipsenthal L.
      • Guarneri M.
      • Finkel R.
      • Saunders Jr, D.E.
      • et al.
      Improvement in medical risk factors and quality of life in women and men with coronary artery disease in the Multicenter Lifestyle Demonstration Project.
      and Ornish.
      • Ornish D.
      Avoiding revascularization with lifestyle changes the Multicenter Lifestyle Demonstration Project.
      A program staff member contacted potential participants after referral to the program by their physicians or by self-referral as a result of local media publicity. Eligible patients (determined by interview) were sent a description of data collection activities, a release form for medical records, and a medical history questionnaire (including medications). A baseline physical assessment (anthropometrics) was completed during the interview. A second interview was scheduled with the hospital team after the intake interview and records review; this included administration of psychosocial and behavioral questionnaires, instructions for completion of a 3-day diet diary, a blood draw for a baseline lipid profile, and a treadmill exercise stress test. Medical and behavioral variables and quality of life were reassessed at 3 and 12 months.

      Subjects

      The protocol was approved by the committee on the protection of rights of human subjects and written informed consent was obtained from participants. The sample consisted of 440 subjects with CAD (347 men, 55 with DM; 15.9%; 93 women, 36 with DM; 38.7%) who participated in the intervention arm of the MLDP. The group with DM included 3 men (0.9% of the male sample) and 6 women (6.5% of the female sample) with type 1 DM. Eligibility criteria for study participation have been reported previously.
      • Koertge J.
      • Weidner G.
      • Elliott-Eller M.
      • Scherwitz L.
      • Merritt-Worden T.A.
      • Marlin R.
      • Lipsenthal L.
      • Guarneri M.
      • Finkel R.
      • Saunders Jr, D.E.
      • et al.
      Improvement in medical risk factors and quality of life in women and men with coronary artery disease in the Multicenter Lifestyle Demonstration Project.
      • Ornish D.
      Avoiding revascularization with lifestyle changes the Multicenter Lifestyle Demonstration Project.
      Briefly, patients did not smoke, had a diagnosis of CAD, and a history of coronary artery bypass surgery or percutaneous transluminal coronary angioplasty.
      • Koertge J.
      • Weidner G.
      • Elliott-Eller M.
      • Scherwitz L.
      • Merritt-Worden T.A.
      • Marlin R.
      • Lipsenthal L.
      • Guarneri M.
      • Finkel R.
      • Saunders Jr, D.E.
      • et al.
      Improvement in medical risk factors and quality of life in women and men with coronary artery disease in the Multicenter Lifestyle Demonstration Project.

      Measurements

      History of hypertension, hyperlipidemia, myocardial infarction, chest pain, cerebrovascular accident, DM, revascularization procedures, and familial CAD were assessed. Patients were classified as having type 1 or type 2 DM according to guidelines of the American Diabetes Association.
      American Diabetes Association
      Consensus development conference on the diagnosis of coronary heart disease in people with diabetes.
      Medical variables, including height, weight, percent body fat (skin fold measurement), blood pressure,
      • Perloff D.
      • Grim C.
      • Flack J.
      • Frohlich E.D.
      • Hill M.
      • McDonald M.
      • Morgenstern B.Z.
      Human blood pressure determination by sphygmomanometry.
      angina pectoris,
      • Rose G.A.
      • Blackburn H.
      • Gillum R.F.
      • Prineas R.J.
      plasma lipids and lipoproteins, and exercise capacity (i.e., functional capacity as assessed by symptom-limited maximal graded exercise testing using the Bruce protocol
      ) were assessed at baseline and at 3 and 12 months. METs, a measurement of energy expenditure, were automatically calculated by the testing device during exercise testing (1 MET = ∼3.5 mg of oxygen consumed per minute per kilogram of body weight).
      Diet assessment was based on a 3-day food diary.
      • Rimm E.B.
      • Giovannucci E.L.
      • Stampfer M.J.
      • Colditz G.A.
      • Litin L.B.
      • Willett W.C.
      Reproducibility and validity of an expanded self/administered semiquantitative food frequency questionnaire among male health professionals.
      Currently prescribed medications were documented at baseline and at each follow-up. Types of medication included antihypertensives (e.g., angiotensin-converting enzyme inhibitors), vasodilators (e.g., nitrates), serum glucose-lowering agents (regular insulin or oral hypoglycemic agents, such as glipizide [Glucotrol, Pfizer, Inc., New York, New York], glyburide [Micronase, DiaBeta, Pharmacia Upjohn, Kalamazoo, Michigan], tolbutamide [Orinase, Pharmacia Upjohn], metformin [Glucophage, Bristol-Myers Squibb Company, New York, New York]) antilipemics, and antiarrhythmics. Quality of life was assessed by the Medical Outcomes Study 36-item short-form health survey (MOS SF-36) at baseline and at 3 and 12 months.
      • Ware J.J.
      • Sherbourne C.D.
      The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection.
      To summarize the physical and mental components of the MOS SF-36, 2 aggregate scores were computed.
      • Ware J.E.
      • Kosinski M.
      Higher scores on the survey reflect better quality of life. Validity and reliability information of the MOS SF-36 and its summary scores have been previously reported.
      • Jenkinson C.
      • Wright L.
      • Coulter A.
      Criterion validity and reliability of the SF-36 in a population sample.
      • Ware J.E.
      • Gandek B.
      • Kosinski M.
      • Aaronson N.K.
      • Apolone G.
      • Brazier J.
      • Bullinger M.
      • Kaasa S.
      • Leplège A.
      • Prieto L.
      • et al.
      The equivalence of SF-36 summary health scores estimated using standard and country-specific algorithms in 10 countries results from the IQOLA Project.

      Intervention: the Lifestyle Change Program

      The program began with a 12-hour orientation seminar at the hospital that was offered over 2 to 3 days and consisted of scientific lectures and demonstrations (e.g., cooking). Patients then attended sessions in groups 3 times per week for 12 weeks. Two of the 3 weekly sessions focused on the program components in 1-hour blocks. The third weekly session consisted of a 1-hour aerobic exercise session (e.g., on treadmills) and 1-hour lectures that were designed to facilitate long-term adherence to the program. Patients continued to meet in groups weekly for the next 40 weeks. In addition, they were instructed to exercise and practice stress management on their own (also see Koertge et al,
      • Koertge J.
      • Weidner G.
      • Elliott-Eller M.
      • Scherwitz L.
      • Merritt-Worden T.A.
      • Marlin R.
      • Lipsenthal L.
      • Guarneri M.
      • Finkel R.
      • Saunders Jr, D.E.
      • et al.
      Improvement in medical risk factors and quality of life in women and men with coronary artery disease in the Multicenter Lifestyle Demonstration Project.
      Ornish,
      • Ornish D.
      and Billings
      • Billings J.H.
      Maintenance of behavior change in cardiorespiratory risk reduction a clinical perspective from the Ornish program for reversing heart disease.
      ).

      Adherence to the Lifestyle Change Program

      Diet was measured as percent calories from fat (based on 3-day food diary, goal 10%), exercise as hours per week (according to guidelines of the American College of Sports Medicine,
      goal 3 hours/week), stress management as hours per week (goal 1 hour/day), and attendance of the intervention group as the number of sessions attended divided by the number of sessions offered.

      Statistical analysis

      Comparisons of group differences (presence/absence of DM, first-year graduate vs drop-out) in baseline demographic, clinical, risk factor, and psychosocial variables were performed with 2-sample t tests (for continuous variables) and chi-square tests (for categorical variables) for men and women separately. Analyses of variance for repeated measures with 2 between factors (gender and DM status) and 1 within factor at 3 levels (time: baseline, 3 months, and 1 year) were computed to test for the effects of gender, DM, time, and their interactions on coronary risk factors, lifestyle behaviors, and quality of life. To control for unequal numbers in the analyses, analyses of variance for repeated measures with unweighted sums of squares were computed.
      • Tabachnick B.G.
      • Fidell L.S.

      SPSS Base 10.0 User’s Guide. Chicago: SPSS, Inc., 1999.

      • Diehl J.M.
      • Staufenbiel T.
      Bonferroni’s adjustments were made for comparisons across baseline, 3 months, and 12 months.
      • Diehl J.M.
      • Staufenbiel T.
      However, because the 10 medical outcomes are highly correlated (e.g., cholesterol and low-density lipoprotein, systolic and diastolic blood pressures), adjustments for multiple measurements were applied as follows: we computed a p value midway between the nominal p value of the variable under consideration and the p value that was adjusted for all 10 outcomes (K) ([nominal p +Kp]/2). Resulting nonsignificant findings are listed in Table 1. All analyses were preformed with and without data from the 9 patients with type 1 DM; no significant differences emerged, so results are reported on the entire sample. SPSS 10.1 (SPSS, Inc., Chicago, Illinois) was used to perform statistical analysis.
      Table 1Medical risk factors, adherence to lifestyle intervention, and quality of life of patients with complete data at baseline and at three and 12 months by diabetic status and gender
      Analyses of variance for repeated measures with 2 between factors (gender and DM status) and 1 within factor (time: baseline, 3 months, and 1 year). Values are means ± SDs numbers of patients. Means in the same row that do not share superscript letters indicate significant changes over time (p <0.05).
      MeasurementDM StatusBaseline3 Months12 Monthsp Value
      TimeDM StatusGender
      Body weight (kg)Diabetic men95.3 ± 18.9 (43)a90.9 ± 16.7b89.9 ± 15.6b<0.001<0.01<0.001
      Nondiabetic men85.7 ± 15.8 (220)a81.3 ± 13.3b81.0 ± 13.1b
      Diabetic women80.3 ± 17.4 (21)a76.4 ± 16.3b75.2 ± 15.5b
      Nondiabetic women75.5 ± 17.7 (43)a70.6 ± 16.2b69.7 ± 16.3b
      Body fat (%)Diabetic men24.6 ± 6.8 (40)a21.9 ± 6.4b20.7 ± 6.3b<0.0010.158<0.001
      Nondiabetic men22.3 ± 5.8 (195)a19.4 ± 5.0b18.8 ± 5.2b
      Diabetic women35.4 ± 6.1 (17)a31.1 ± 7.5b30.4 ± 7.1b
      Nondiabetic women34.9 ± 5.5 (37)a31.8 ± 5.6b30.5 ± 5.8b
      Systolic blood pressure (mm Hg)Diabetic men137 ± 19 (40)a132 ± 19a134 ± 21a0.7950.1310.735
      Nondiabetic men131 ± 18 (165)a126 ± 18a128 ± 18a
      Diabetic women132 ± 15 (18)a129 ± 16a132 ± 20a
      Nondiabetic women136 ± 20 (33)a129 ± 19a134 ± 16a
      Diastolic blood pressure (mm Hg)Diabetic men80 ± 10 (40)a74 ± 9b75 ± 11b<0.03
      Adjustments for multiple medical outcomes rendered this finding nonsignificant. After adjusting for multiple medical outcomes, only 1 significant 2-way interaction remained that involved time and DM on heart rate at rest. Two additional significant 2-way interactions could be found: 1 2-way interaction involving gender and DM on mental health and 1 2-way interaction involving the effects of gender and time on dietary fat. These effects indicated lowest heart rates among patients without DM at 1 year and lowest mental health scores among women with DM. The highest fat intake was observed among women at baseline.
      <0.02
      Adjustments for multiple medical outcomes rendered this finding nonsignificant. After adjusting for multiple medical outcomes, only 1 significant 2-way interaction remained that involved time and DM on heart rate at rest. Two additional significant 2-way interactions could be found: 1 2-way interaction involving gender and DM on mental health and 1 2-way interaction involving the effects of gender and time on dietary fat. These effects indicated lowest heart rates among patients without DM at 1 year and lowest mental health scores among women with DM. The highest fat intake was observed among women at baseline.
      0.900
      Nondiabetic men79 ± 10 (164)a74 ± 11b76 ± 10b
      Diabetic women77 ± 11 (18)a72 ± 14b72 ± 10b
      Nondiabetic women81 ± 8 (33)a77 ± 10b78 ± 11b
      Heart rate at rest (beats/min)Diabetic men73 ± 14 (38)a69 ± 13b72 ± 13a<0.001<0.05
      Adjustments for multiple medical outcomes rendered this finding nonsignificant. After adjusting for multiple medical outcomes, only 1 significant 2-way interaction remained that involved time and DM on heart rate at rest. Two additional significant 2-way interactions could be found: 1 2-way interaction involving gender and DM on mental health and 1 2-way interaction involving the effects of gender and time on dietary fat. These effects indicated lowest heart rates among patients without DM at 1 year and lowest mental health scores among women with DM. The highest fat intake was observed among women at baseline.
      <0.01
      Nondiabetic men68 ± 13 (178)a64 ± 11b67 ± 12a
      Diabetic women77 ± 11 (19)a73 ± 14b77 ± 12a
      Nondiabetic women76 ± 14 (33)a71 ± 14b73 ± 12a
      Total serum cholesterol (mg/dl)Diabetic men199 ± 55 (41)a177 ± 69b171 ± 37b0.0520.704<0.01
      Nondiabetic men195 ± 57 (207)a177 ± 55b180 ± 37b
      Diabetic women210 ± 33 (20)a204 ± 43b192 ± 41b
      Nondiabetic women222 ± 42 (40)a204 ± 39b204 ± 44b
      Low-density lipoprotein cholesterol (mg/dl)Diabetic men116 ± 37 (35)a97 ± 32b95 ± 27b<0.010.401<0.05
      Adjustments for multiple medical outcomes rendered this finding nonsignificant. After adjusting for multiple medical outcomes, only 1 significant 2-way interaction remained that involved time and DM on heart rate at rest. Two additional significant 2-way interactions could be found: 1 2-way interaction involving gender and DM on mental health and 1 2-way interaction involving the effects of gender and time on dietary fat. These effects indicated lowest heart rates among patients without DM at 1 year and lowest mental health scores among women with DM. The highest fat intake was observed among women at baseline.
      Nondiabetic men121 ± 48 (193)a101 ± 41b105 ± 34b
      Diabetic women125 ± 31 (19)a115 ± 35b101 ± 23b
      Nondiabetic women135 ± 40 (39)a115 ± 39b116 ± 36b
      High-density lipoprotein cholesterol (mg/dl)Diabetic men35 ± 12 (38)a31 ± 9b34 ± 9a,b0.1220.162<0.001
      Nondiabetic men35 ± 10 (198)a31 ± 8b34 ± 9a,b
      Diabetic women41 ± 10 (20)a38 ± 10b41 ± 12a,b
      Nondiabetic women47 ± 13 (40)a43 ± 16b47 ± 15a,b
      Triglycerides (mg/dl)
      Winsorizing statistical outliers (i.e., replacing values ± 3 SDs of the mean with “most extreme acceptable values” in the distribution of this variable) did not yield significantly different results.
      Diabetic men321 ± 488 (41)a277 ± 251a280 ± 359a0.8040.1770.409
      Nondiabetic men213 ± 158 (204)a230 ± 166a222 ± 129a
      Diabetic women240 ± 155 (20)a262 ± 151a248 ± 176a
      Nondiabetic women202 ± 83 (40)a244 ± 173a208 ± 97a
      Exercise capacity (METs; ml O2/min/kg)Diabetic men8.8 ± 2.8 (37)a10.8 ± 2.7b10.8 ± 2.4b<0.001<0.01<0.001
      Nondiabetic men10.4 ± 2.9 (180)a11.9 ± 2.6b12.5 ± 2.8b
      Diabetic women6.9 ± 2.1 (20)a8.4 ± 2.6b8.5 ± 2.8b
      Nondiabetic women8.3 ± 2.8 (33)a9.0 ± 2.9b10.0 ± 3.0b
      Diet (% calories from fat)Diabetic men14.2 ± 7.8 (38)a6.5 ± 2.1b6.4 ± 2.8b<0.001<0.04<0.001
      Nondiabetic men12.6 ± 7.8 (172)a6.2 ± 2.3b6.2 ± 2.6b
      Diabetic women19 ± 7.7 (20)a7.1 ± 2.1b8.9 ± 5.3b
      Nondiabetic women15.9 ± 8.7 (33)a6.8 ± 2.5b7.1 ± 3.3b
      Exercise (h/wk)Diabetic men1.8 ± 1.7 (44)a4.0 ± 3.3b3.8 ± 2.5b<0.0010.500<0.001
      Nondiabetic men2.4 ± 2.0 (217)a4.1 ± 2.1b3.6 ± 2.1b
      Diabetic women1.1 ± 1.1 (28)a3.0 ± 1.3b2.8 ± 1.4b
      Nondiabetic women1.6 ± 1.5 (46)a3.3 ± 1.5b3.0 ± 1.7b
      Stress management (h/wk)Diabetic men0.5 ± 1.3 (45)a5.5 ± 2.4b4.6 ± 2.6b<0.001<0.020.317
      Nondiabetic men0.5 ± 1.3 (218)a5.6 ± 2.5b4.8 ± 2.9b
      Diabetic women0.3 ± 0.7 (28)a4.9 ± 2.7b3.5 ± 2.8b
      Nondiabetic women0.6 ± 1.1 (46)a5.7 ± 2.2b5.1 ± 2.5b
      Intervention group (% attendance)Diabetic men0.93 ± 0.08 (51)a080 ± 0.19b<0.0010.570<0.03
      Nondiabetic men0.93 ± 0.10 (272)a0.78 ± 0.20b
      Diabetic women0.89 ± 0.13 (33)a0.71 ± 0.21b
      Nondiabetic women0.92 ± 0.10 (54)a0.76 ± 0.23b
      MOS SF-36
      Physical health
      Scores were standardized to have a mean of 50 and an SD of 10 based on a 1998 representative sample of the general United States population.
      Diabetic men43.6 ± 8.6 (42)a48.2 ± 8.2b48.5 ± 7.7b<0.001<0.01<0.02
      Nondiabetic men48.6 ± 9.1 (211)a51.8 ± 7.5b52.9 ± 7.3b
      Diabetic women41.7 ± 8.1 (23)a47.5 ± 7.3b46.8 ± 6.3b
      Nondiabetic women43.3 ± 9.6 (43)a47.7 ± 8.8b50.6 ± 7.9b
      Mental health
      Scores were standardized to have a mean of 50 and an SD of 10 based on a 1998 representative sample of the general United States population.
      Diabetic men46.5 ± 12.1 (42)a50.3 ± 9.2b51.8 ± 10.1b<0.001<0.010.053
      Nondiabetic men48.4 ± 10.3 (211)a52.9 ± 8.8b52.1 ± 9.7b
      Diabetic women40.0 ± 10.1 (23)a47.4 ± 10.5b46.2 ± 12.5b
      Nondiabetic women47.5 ± 9.7 (43)a54.4 ± 8.9b52.0 ± 9.2b
      low asterisk Analyses of variance for repeated measures with 2 between factors (gender and DM status) and 1 within factor (time: baseline, 3 months, and 1 year). Values are means ± SDs numbers of patients. Means in the same row that do not share superscript letters indicate significant changes over time (p <0.05).
      Winsorizing statistical outliers (i.e., replacing values ± 3 SDs of the mean with “most extreme acceptable values” in the distribution of this variable) did not yield significantly different results.
      Scores were standardized to have a mean of 50 and an SD of 10 based on a 1998 representative sample of the general United States population.
      § Adjustments for multiple medical outcomes rendered this finding nonsignificant. After adjusting for multiple medical outcomes, only 1 significant 2-way interaction remained that involved time and DM on heart rate at rest. Two additional significant 2-way interactions could be found: 1 2-way interaction involving gender and DM on mental health and 1 2-way interaction involving the effects of gender and time on dietary fat. These effects indicated lowest heart rates among patients without DM at 1 year and lowest mental health scores among women with DM. The highest fat intake was observed among women at baseline.

      Results

      Baseline characteristics

      Baseline characteristics are presented in Table 2, Table 3. Patients with DM did not differ from patients without DM in age, education, marital status, and spousal support. Patients with DM were less likely to be employed outside the home than were patients without DM. Men (but not women) with DM were more likely to have a history of hypertension, hyperlipidemia, and angina pectoris during the previous 30 days than were men without DM. Among men, body mass index, body weight, systolic blood pressure, and heart rate at rest were significantly higher among those with DM than among those without DM. Women with DM weighed more than did women without DM. Men and women with DM had lower METs than did those without DM. Patients with DM did not differ from patients without DM in diastolic blood pressure and plasma lipids. Men and women with DM reported an overall lower quality of life than did those without DM. There were no significant group differences in health behaviors, except that patients with DM exercised significantly less than did their counterparts without DM. Men and women with DM were significantly more often prescribed nitrates than were those without DM. Further, men with DM were more often prescribed angiotensin-converting enzyme inhibitors and calcium channel blockers than were those without DM. The same pattern of prescription was observed for angiotensin-converting enzyme inhibitors among women, but not for calcium channel blockers (for serum glucose-lowering agents at baseline and follow-up in patients with DM, see Table 4).
      Table 2Demographic and medical characteristics at baseline
      VariableDiabetic Men (n = 55)Nondiabetic Men (n = 286)p ValueDiabetic Women (n = 36)Nondiabetic Women (n = 57)p Value
      Age (yrs)59 ± 1058 ± 110.5458 ± 1160 ± 100.19
      Education (yrs)16 ± 316 ± 30.6815 ± 315 ± 30.44
      Married or cohabitating47 (85%)253 (88%)0.9823 (64%)35 (61%)0.10
      Employed outside the home33 (60%)202 (70%)<0.0511 (31%)31 (54%)0.06
      Spousal participation30 (55%)138 (48%)0.078 (22%)15 (26%)0.87
      Family history of CAD
      Family history of CAD was considered positive if a male (<60 years of age) or female (<70 years of age) first-degree relative had CAD, myocardial infarction, or a cerebrovascular accident.
      40 (73%)156 (54%)0.0823 (66%)35 (61%)0.38
      Previous cigarette smoker40 (73%)199 (69%)0.7019 (53%)33 (58%)0.63
      Systemic hypertension41 (75%)121 (42%)<0.0123 (64%)29 (51%)0.38
      Hyperlipidemia
      Hyperlipidemia was defined as a low-density lipoprotein cholesterol level >100 mg/dl, a high-density lipoprotein cholesterol level ≤35 mg/dl, or a triglyceride level ≥200 mg/dl (National Cholesterol Education Program guidelines, Adult Treatment Panel II for individuals with established coronary heart disease).
      36 (66%)170 (59%)<0.0124 (67%)42 (74%)0.70
      Previous myocardial infarction24 (44%)157 (54%)0.3617 (47%)37 (65%)0.09
      Previous coronary angioplasty20 (36%)137 (47%)0.1021 (58%)26 (46%)0.23
      Previous coronary bypass31 (56%)139 (48%)0.5214 (39%)17 (30%)0.37
      Angina pectoris (during past 30 d)34 (63%)110 (38%)<0.0117 (47%)32 (56%)0.40
      Medication
      Nitrates22 (40%)76 (26%)<0.0518 (50%)15 (26%)<0.05
      β Blockers23 (42%)145 (50%)0.1920 (56%)25 (44%)0.27
      Angiotensin-converting enzyme inhibitors21 (38%)49 (17%)<0.0110 (28%)11 (19%)0.34
      Calcium antagonists35 (64%)124 (43%)<0.0523 (64%)37 (65%)0.92
      Diuretics8 (15%)22 (8%)0.2211 (31%)12 (21%)0.30
      Antihypertensives5 (9%)13 (5%)0.351 (3%)1 (2%)0.74
      Lipid-lowering therapy30 (55%)149 (51%)0.3116 (44%)36 (63%)0.08
      low asterisk Family history of CAD was considered positive if a male (<60 years of age) or female (<70 years of age) first-degree relative had CAD, myocardial infarction, or a cerebrovascular accident.
      Hyperlipidemia was defined as a low-density lipoprotein cholesterol level >100 mg/dl, a high-density lipoprotein cholesterol level ≤35 mg/dl, or a triglyceride level ≥200 mg/dl (National Cholesterol Education Program guidelines, Adult Treatment Panel II for individuals with established coronary heart disease).
      Table 3Medical risk factors, lifestyle behavior, and quality of life at baseline
      VariableDiabetic Men (n = 55)Nondiabetic Men (n = 286)p ValueDiabetic Women (n = 36)Nondiabetic Women (n = 57)p Value
      Systolic blood pressure (mm Hg)139 ± 21130 ± 19<0.01135 ± 19135 ± 190.98
      Diastolic blood pressure (mm Hg)81 ± 1079 ± 100.3377 ± 1079 ± 100.34
      Heart rate at rest (beats/min)73 ± 1468 ± 12<0.0578 ± 1273 ± 140.09
      Body mass index (kg/m2)30.5 ± 5.827.3 ± 5.2<0.0130.7 ± 5.528.8 ± 7.10.19
      Body weight (kg)92.8 ± 18.086.1 ± 15.6<0.0181.6 ± 16.873.5 ± 16.8<0.05
      Body fat (%)24.5 ± 722.8 ± 5.90.0734.7 ± 6.334.2 ± 5.60.72
      Total serum cholesterol (mg/dl)197 ± 52195 ± 540.84214 ± 41226 ± 480.24
      Low-density lipoprotein cholesterol (mg/dl)114 ± 38119 ± 460.50133 ± 36138 ± 440.63
      High-density lipoprotein cholesterol (mg/dl)35 ± 1135 ± 100.9443 ± 1245 ± 120.50
      Triglycerides (mg/dl)244 ± 142216 ± 1560.23228 ± 140217 ± 930.66
      Exercise capacity (METs; ml O2/min/kg)8.7 ± 2.910.2 ± 2.9<0.016.7 ± 1.98.1 ± 2.4<0.01
      Diet (% calories from fat)14.4 ± 8.312.9 ± 8.40.2617.8 ± 7.816.4 ± 9.40.50
      Exercise (h/wk)1.7 ± 1.72.4 ± 2.2<0.051 ± 1.11.7 ± 1.5<0.05
      Stress management (h/wk)0.5 ± 1.30.5 ± 1.30.690.37 ± 0.780.83 ± 1.50.10
      MOS SF-36: physical health
      Scores were standardized to have a mean of 50 and an SD of 10 based on a 1998 representative sample of the general United States population.
      43.1 ± 9.048.3 ± 8.9<0.0139.4 ± 8.544.0 ± 9.5<0.05
      MOS SF-36: mental health
      Scores were standardized to have a mean of 50 and an SD of 10 based on a 1998 representative sample of the general United States population.
      46.5 ± 11.448.1 ± 10.10.3243.0 ± 10.347.7 ± 9.7<0.05
      low asterisk Scores were standardized to have a mean of 50 and an SD of 10 based on a 1998 representative sample of the general United States population.
      Table 4Changes in glucose-lowering regimen from baseline to one year among patients with diabetes mellitus (n = 91)
      Changes
      Five patients with DM (5.4%) dropped out by the 1-year follow-up; 2 were on an insulin regimen, 2 on an oral antiglycemic agent, and 1 was not medicated at baseline.
      Baseline
      Five patients with DM (5.4%) dropped out by the 1-year follow-up; 2 were on an insulin regimen, 2 on an oral antiglycemic agent, and 1 was not medicated at baseline.
      1 Year
      No change: 62 (68.1%)
      16 (17.6%)No medication, insulin levels controlled by dietNo medication, insulin levels controlled by diet
      25 (27.5%)InsulinInsulin
      21 (23.1%)Oral antiglycemicOral antiglycemic
      Improvement: 18 (20%)
      1InsulinDiscontinued insulin without adopting another medical regimen
      6InsulinOral antiglycemic
      11Oral antiglycemicDiscontinued oral antiglycemic without adopting another regimen
      Worsening: 6 (6.6%)
      1Oral antiglycemicInsulin
      1No medicationInsulin
      4No MedicationOral antiglycemic
      low asterisk Five patients with DM (5.4%) dropped out by the 1-year follow-up; 2 were on an insulin regimen, 2 on an oral antiglycemic agent, and 1 was not medicated at baseline.

      Participant characteristics at follow-ups

      Measurements of anthropometric and medical variables, adherence to the program, and quality of life of patients with complete data at all time points are presented in Table 1. Regardless of gender or DM, all patients lost a significant amount of weight and body fat, significantly lowered their heart rates and levels of low-density lipoprotein cholesterol, and increased their METs. Most of the changes were already evident at 3 months and were maintained over 1 year.
      On average, improvement in patients with DM was the same as in patients without DM, although patients with DM weighed more, had a greater percentage of body fat, higher heart rates at rest, and lower METs than did patients without DM across follow-up time points. Women had significantly lower levels of high-density lipoprotein cholesterol than did men regardless of DM. By the end of 1-year follow-up, all patients significantly improved their diet, exercise, and stress management. All patients met program recommendations with regard to diet. All patients, except women with DM (2.8 ± 1.4 hours of exercise per week), exercised the prescribed amount of 3 hours per week. However, patients with DM practiced stress management for only 4 hours/week (patients without DM practiced 5 hours/week). Women with DM reported practicing less stress management compared with women without DM at all 3 time points. Attendance of group support sessions decreased significantly over time. Patients with DM attended an average of 91% and patients without DM attended an average of 92% of the group support meetings offered during the first 3 months of the intervention. At 1 year, an average of 76% of the group meetings were attended by patients with DM and 78% by those without DM. Patients with DM and women as a group reported lower quality of life at all 3 time points. However, all patients, regardless of gender and DM status, improved their quality of life over time (Table 1).

      Participants lost to follow-up

      For a comparison of those who completed the 12-month follow-up with those who did not (21% of men and 27% of women), see our previous report.
      • Koertge J.
      • Weidner G.
      • Elliott-Eller M.
      • Scherwitz L.
      • Merritt-Worden T.A.
      • Marlin R.
      • Lipsenthal L.
      • Guarneri M.
      • Finkel R.
      • Saunders Jr, D.E.
      • et al.
      Improvement in medical risk factors and quality of life in women and men with coronary artery disease in the Multicenter Lifestyle Demonstration Project.
      Briefly, women who completed follow-up were younger and more likely to be employed at baseline; men who completed the study reported a worse medical history at baseline but indicated more partner support. Within the DM sample (n = 91), a comparison of those who completed the program (n = 69, 76%) with those who did not (n = 22, 24%) showed that those who completed the program were significantly younger (p <0.01) and had more years of education (p <0.05). No other differences emerged. Drop-out rates in the MLDP ranged from 21% to 27% depending on gender and DM status and compared favorably with those in other follow-up studies with cardiac patients.
      • Carney R.M.
      • Blumenthal J.A.
      • Freedland K.E.
      • Youngblood M.
      • Veith R.C.
      • Burg M.M.
      • Cornell C.
      • Saab P.G.
      Depression and late mortality after myocardial infarction in the enhancing recovery in coronary heart disease (ENRICHD) study.
      • Ades P.A.
      Cardiac rehabilitation and secondary prevention of coronary heart disease.

      Discussion

      The results of the present study indicate that, despite their worse medical and psychosocial risk factor profiles at program entry (also evident in other studies
      • Suresh V.
      • Harrison R.A.
      • Houghton P.
      • Naqvi N.
      Standard cardiac rehabilitation is less effective for diabetics.
      • Banzer J.A.
      • Maguire T.E.
      • Kennedy C.M.
      • O’Malley C.J.
      • Ballady G.J.
      Results of cardiac rehabilitation in patients with diabetes mellitus.
      • Milani R.V.
      • Lavie C.J.
      Behavioral differences and effects of cardiac rehabilitation in diabetic patients following cardiac events.
      ), patients with CAD and DM are able to make comprehensive lifestyle changes. At 3 months, improvement in risk factors, lifestyle, and quality of life of patients with CAD and DM paralleled that of patients without DM and was maintained for the entire follow-up. Even women with DM, the most medically and psychosocially disadvantaged group in our sample, were able to follow the intervention and showed significant improvements in CAD risk factors (e.g., weight, body fat, low-density lipoprotein cholesterol, and METs but no change in high-density lipoprotein cholesterol and triglycerides) and quality of life. These findings underscore the need for more aggressive approaches, such as intensive multicomponent interventions, when targeting patients with CAD and DM.
      • Banzer J.A.
      • Maguire T.E.
      • Kennedy C.M.
      • O’Malley C.J.
      • Ballady G.J.
      Results of cardiac rehabilitation in patients with diabetes mellitus.
      Medicare is currently conducting a National Demonstration Project that is testing the feasibility and cost effectiveness of such an intervention for patients with CAD with and without DM.

      Centers for Medicare & Medicaid Services. Announcement of the implementation of the Medicare Lifestyle Modification Program Demonstration Project. Federal Register Notice. January 5, 2000. Available at: http://www.cms.hhs.gov/researchers/demos/preventiveservices/3q4.asp. Accessed July 5, 2005

      Quality of life also improved in the 2 groups of patients at 3 months and was maintained at 1 year. Because the MOS SF-36 correlates negatively with measures of depression,
      • Callahan E.J.
      • Bertakis K.D.
      • Azari R.
      • Helms L.J.
      • Robbins J.
      • Miller J.
      Depression in primary care patient factors that influence recognition.
      • McKee M.D.
      • Cunningham M.
      • Jankowski K.R.
      • Zayas L.
      Health-related functional status in pregnancy relationship to depression and social support in a multi-ethnic population.
      • Nemeroff C.B.
      • O’Connor C.M.
      Depression as a risk factor for cardiovascular and cerebrovascular disease emerging data and clinical perspectives.
      increased quality of life may also indicate decreased depression, a risk factor for CAD,
      • Nemeroff C.B.
      • O’Connor C.M.
      Depression as a risk factor for cardiovascular and cerebrovascular disease emerging data and clinical perspectives.
      especially among women with DM.
      • Clouse R.E.
      • Lustman P.J.
      • Freedland K.E.
      • Griffith L.S.
      • McGill J.B.
      • Carney R.M.
      Depression and coronary heart disease in women with diabetes.
      One limitation of the present study was that the intervention group of the MLDP, but not the matched control group, had systematic assessment of coronary risk factors and quality of life.
      • Ornish D.
      Avoiding revascularization with lifestyle changes the Multicenter Lifestyle Demonstration Project.
      Thus, inferences about the effectiveness of the intervention cannot be made. Further, as in any multicomponent intervention, we do not know the relative importance of each component. Although the role of exercise and diet in CAD prevention is fairly well established,
      • Ades P.A.
      Cardiac rehabilitation and secondary prevention of coronary heart disease.
      there is evidence that stress management may decrease clinical events in patients with CAD,
      • Blumenthal J.A.
      • Babyak M.
      • Wei J.
      • O’Connor C.
      • Waugh R.
      • Eisenstein E.
      • Mark D.
      • Sherwood A.
      • Woodley P.S.
      • Irwin R.J.
      • Reed G.
      Usefulness of psychosocial treatment of mental stress-induced myocardial ischemia in men.
      decrease hemoglobin A1c in patients with DM,
      • Surwit R.S.
      • van Tilburg M.A.
      • Zucker N.
      • McCaskill C.C.
      • Parekh P.
      • Feinglos M.N.
      • Edwards C.L.
      • Williams P.
      • Lane J.D.
      Stress management improves long-term glycemic control in type 2 diabetes.
      and affect DM control by facilitating adherence to diet or exercise regimens that are often prescribed for DM management.
      • Surwit R.S.
      • Schneider M.S.
      Role of stress in the etiology and treatment of diabetes mellitus.

      Acknowledgment

      Special appreciation is expressed to Vance Smith, MPH, and Mutual of Omaha, Omaha, Nebraska. We also thank Billy Gao, BS, for invaluable assistance and Nancy R Mendell, PhD, for helpful comments.

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