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Finnish Diabetes Prevention Study - Finnish Diabetes Prevention Study
Description:
The goal of the trial was to evaluate whether treatment with a prevention intervention program would be associated with reduction in the development of diabetes in overweight, nondiabetic patients at high risk for diabetes.
Study Design
Study Design:
Patients Enrolled: 522
Mean Follow Up: Mean follow-up 3.2 years
Mean Patient Age: Mean age 55 years
Female: 67
Patient Populations:
Body mass index ≥25, age 40-65 years, and had impaired glucose tolerance, defined as a plasma glucose concentration after an overnight fast of <140 mg/dl and two measures of plasma glucose of 140-200 mg/dl two hours after the oral administration of 75 g of glucose
Exclusions:
Diabetes mellitus, presence of chronic disease rendering survival for six years unlikely, and other characteristics (psychological or physical disabilities) deemed likely to interfere with participation in the study
Drug/Procedures Used:
Patients were randomized to the intervention group (n=265) or the control group (n=257). Goals for the intervention group included ≥5% weight loss; intake of fat <30% of energy consumed, and intake of saturated fat <10% of energy consumed; an increase in fiber intake to ≥15 g per 1000 kcal and ≥30 minutes of physical activity per day. The goals were to be addressed via sessions with a nutritionist on diet and individual guidance on increasing level of physical activity.
Principal Findings:
Mean body mass index at baseline was 31 and baseline fasting glucose averaged 109 mg/dl. Compared with the control group, more patients in the intervention group achieved the prespecified goals, including weight loss of >5% (43% vs. 13%), fat intake <30% (47% vs. 26%), saturated fat intake <10% (26% vs. 11%), and >4 hours per week of exercise (86% vs. 71%, all p=0.001).
Average weight loss was greater in the intervention group compared with the control group at one year (4.2 kg vs. 0.8 kg, p<0.001) and was maintained at two years (3.5 kg vs. 0.8 kg, p<0.001). Also greater in the intervention group were reductions in fasting glucose (-4 mg/dl vs. +1 mg/dl, p<0.001), triglycerides (-18 mg/dl vs. -1 mg/dl, p=0.001), and systolic and diastolic blood pressure (-5/-5 mm Hg vs. -1/-3 mmHg, p<0.01 each).
Development of diabetes by four years occurred less frequently in the intervention group than the control group (11% vs. 23%, a 58% reduction, p<0.001). Twenty-three patients in the intervention group and 17 in the control group withdrew from the study.
Interpretation:
Among overweight, nondiabetic patients at high risk for diabetes, use of a lifestyle modification intervention program was associated with a reduction in the development of diabetes and improvement in diabetic risk factors compared with control.
Development of diabetes in high-risk patients is preventable with a lifestyle modification intervention program as was shown in the present trial as well as other studies, including the Diabetes Prevention Program Trial, which demonstrated a 58% reduction in new onset of diabetes. Based on the results of the present trial, 22 patients with impaired glucose tolerance would need to be treated with such an intervention program to prevent one case of diabetes.
References:
Tuomilehto J, Lindstrom J, Eriksson JG, et al. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med 2001;344:1343-50.
Keywords: Life Style, Behavior Therapy, Overweight, Weight Loss, Blood Pressure, Risk Factors, Glucose Intolerance, Body Mass Index, Motor Activity, Diet, Nutritionists, Triglycerides, Diabetes Mellitus, Fasting
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