Aim: To evaluate whether a prospective randomised controlled trial of intensive lifestyle intervention delivered on a monthly out-patient basis can result in reduced cardiovascular risk, and improved quality of life in obese patients with type 2 diabetes.
Patients and Methods: Patients were recruited from diabetes out-patient clinics. All subjects underwent a treadmill exercise test to assess eligibility before randomization. Subjects with a negative exercise test were randomized either to lifestyle intervention or to dietary advice only (controls). Cardiovascular risk was estimated using the UKPDS risk engine; quality of life was measured using the SF-36. Ethical approval was obtained for this study.
Results: Sixty-two subjects were suitable for randomization; 56 completed the six-month study period. At baseline there were significant negative associations between the General Health score on the SF-36 and high sensitivity C-reactive protein (r=−0.39, P<0.01) and between both Mental Health and Social Functioning and HOMA (r=−0.29, P<0.05 and r=−0.36, P<0.01, respectively).
At six months there was no significant weight change overall in either the active or control groups, however in patients in whom weight loss occurred, there was an associated improvement in the SF-36 Physical Functioning score (r=−0.38, P<0.05). Individuals who increased their habitual exercise demonstrated a significant increase in mental health score over this time (from 67.1 to 76.4, P<0.05).
Over the study period there was a small but significant change in waist circumference in the active group (−2.3±5.0 cm, P<0.01). This waist circumference change was positively associated with changes in UKPDS cardiovascular risk score (r=0.4, P<0.05).
Conclusions: Lifestyle intervention even without weight loss is of benefit in patients with obesity and type 2 diabetes. Modest exercise in this study was associated with improvements in quality of life and waist circumference changes that accompanied exercise participation were associated with a reduction in cardiovascular risk score.