SMALL WEIGHT-LOSS ON LONG-TERM ACARBOSE THERAPY WITH NO CHANGE IN DIETARY PATTERN OR NUTRIENT INTAKE OF INDIVIDUALS WITH NON-INSULIN-DEPENDENT DIABETES

OBJECTIVES: To see if the long-term treatment of non-insulin dependent diabetes (NIDDM) with the alpha-glucosidase inhibitor acarbose affect s food intake and body weight. DESIGN: Randomized, double-blind, place bo-controlled, parallel design clinical trial of 12 months duration. S UBJECTS: Subjects with NIDDM in four treatment strata: 77 on diet alon e, 83 also treated with metformin, 103 also treated with sulfonylurea and 91 also treated with insulin. MEASUREMENTS: Two 3 day diet records were obtained before randomization to acarbose or placebo therapy, an d additional 3 day diet records were obtained at 3, 6, 9 and 12 months after randomization. Body weight was also measured at these times. RE SULTS: Of the 354 subjects randomized, 279 (79%) completed at least 9 months of therapy and, of these, 263 (94%) provided at least one diet record during the baseline period and two diet records during the trea tment period. After one year, subjects on acarbose had lost 0.46 +/- 0 .28 kg, which differed significantly from the 0.33 +/- 0.25 kg weight gain on placebo (P = 0.027). The difference in weight change between a carbose and placebo did not differ significantly in the different trea tment strata. Being in the study had significant effects on diet, incl uding a reduction in energy intake from 1760-1700Kcal/d (P<0.05), a re duction in simple sugars intake from 18.5-17.4% of energy (P<0.001), a nd reductions in the number of different foods consumed (33-30, P<0.00 1) and the number of meals eaten per day (4.7-4.3, P<0.001). However, compared to placebo treatment, acarbose had no effect on energy intake , nutrient intakes, or dietary patterns. CONCLUSIONS: In subjects with NIDDM on weight-maintaining diets, long-term acarbose therapy results in a small weight loss, but has no effect on energy or nutrient intak es. The weight loss induced by acarbose may be due partly to reduced d oses of concomitant oral agents and insulin and partly to energy loss due to increased colonic fermentation.