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Item #9

Randomized Trial Demonstrates Benefits of Lifestyle Modification in Type 2 Diabetes
First randomised trial ever to report that people who have a high risk of developing type 2 diabetes mellitus can prevent the disease.

Obesity and physical inactivity have been linked unequivocally to the onset of diabetes. People with impaired glucose tolerance are known to be at increased risk of diabetes and cardiovascular complications of hyperglycemia and should therefore be a focus of prevention efforts, note researchers led by Jaakko Tuomilehto, MD, with the National Public Health Institute, Helsinki, Finland.

To evaluate the effect of lifestyle modification on development of diabetes, the researchers randomized 522 middle-aged, overweight subjects with impaired glucose tolerance to either lifestyle intervention or no intervention. All participants underwent an oral glucose tolerance test annually.

Subjects in the intervention group were given individualised detailed advice about how to achieve the intervention goals. These included weight loss of 5% or more, total daily fat intake of less than 30% of calories, daily saturated fat intake of less than 10% of calories, daily fibre intake of 15 g per 1,000 calories, and moderate daily exercise for 30 minutes or more.

Overall, the intervention group lost more average weight than the control group. The mean weight reduction from baseline to year 1 was 4.2 kg and from baseline to year 2 was 3.5 in the intervention group and 0.8 kg at both time points in the control group, respectively (P<0.001 between the groups).

During a mean follow-up of about 3 years, the risk of diabetes was reduced by 58% (P<0.001) in the intervention group compared with the control group.

"Based on our study, 22 subjects with impaired glucose tolerance need to be treated for 1 year or 5 people for 5 years with a lifestyle intervention to prevent 1 case of diabetes," Dr. Tuomilehto and colleagues predict.

They conclude that primary prevention of diabetes is possible by a nonpharmacological intervention that can be implemented in a primary care setting. J Am Soc Nephrol 2003;14:7 Suppl 2:S108-13.

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