¹Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada M5S 3E2

²Centre de Recherche/Hôtel-Dieu de Montréal, 3850 Rue Saint-Urbain, Montréal, Québec, Canada H2W 1T8

³St. Michael's Hospital, University of Toronto, 61 Queen Street East, Toronto, Ontario, Canada M5C 2T2

⁴Lion's Gate Hospital, University of British Columbia, 1940 Lonsdale Ave, Suite 101, North Vancouver, British Columbia, Canada V7M 2K2

⁵Ceapro Inc., 2830, 10180-101 Street, Edmonton, Alberta, Canada T5J 3S4

⁶Saint Joseph's Health Centre, 268 Grosvenor Street, London, Ontario, Canada N6A 4V2

⁷4411 16th Avenue N.W., Suite 238, Calgary, Alberta, Canada T3D 0M3

⁸Walter C. Mackenzie Health Sciences Centre, University of Alberta, Edmonton, Alberta, Canada T6G 2S2

⁹Camp Hill Medical Centre, Department of Medicine, 5303 Morris Street, Halifax, Nova Scotia, Canada B3J 1B6

Correspondence: Dr TMS Wolever, Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada M5S 3E2

OBJECTIVES: To see if the long-term treatment of non-insulin dependent diabetes (NIDDM) with the -glucosidase inhibitor acarbose affects food intake and body weight. DESIGN: Randomized, double-blind, placebo-controlled, parallel design clinical trial of 12 months duration. SUBJECTS: Subjects with NIDDM in four treatment strata: 77 on diet alone, 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, and additional 3 day diet records were obtained at 3, 6, 9 and 12 months after randomization. Body weight was also measured at these times. RESULTS: 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 treatment 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 acarbose and placebo did not differ significantly in the different treatment strata. Being in the study had significant effects on diet, including a reduction in energy intake from 1760-1700 Kcal/d (P<0.05), a reduction in simple sugars intake from 18.5-17.4% of energy (P<0.001), and reductions in the number of different foods consumed (33-30, P<0.001) 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 intakes. The weight loss induced by acarbose may be due partly to reduced doses of concomitant oral agents and insulin and partly to energy loss due to increased colonic fermentation.

acarbose; humans; diabetes; colonic fermentation; body weight