J Lindström1, J Tuomilehto, M Spengler. 1. National Public Health Institute, Department of Epidemiology and Health Promotion, Mannerheimintie, Helsinki, Finland. jaana.lindstrom@ktl.fi
Abstract
AIMS: It has been speculated that acarbose treatment in patients with Type 2 diabetes mellitus might induce changes in diet as a result of its adverse gastrointestinal effects. The aim of this study was to determine whether poor metabolic control can be improved by acarbose, and whether this might be because the acarbose supplementation provokes changes in diet. METHODS:Poorly controlled Type 2 diabetic patients treated with oral hypoglycaemic agents (OHA) were randomized into either acarbose (100 mg t.d.s.) or placebo treatment. The double-blind treatment lasted for 24 weeks. Four-day food diaries and blood samples for efficacy analysis were collected at 0, 4, 12, and 24 weeks. Thirty-six acarbose and 39 placebo-treated patients completed the trial and were included in the final analyses. RESULTS: At 24 weeks the baseline adjusted means of fasting, 1 and 2-h postprandial blood glucose values were 9.3 vs. 10.5 (P=0.02), 11.6 vs. 14.5 (P<0.001) and 11.0 vs. 13.7 mmol/l (P<0.001) and HbA1 9.3% vs. 10.2% (P=0.002) in the acarbose and placebo groups, respectively. No significant differences in nutrient intakes between groups were observed. The energy intake and energy proportion of fat and carbohydrates remained unchanged in both groups. CONCLUSIONS:Acarbose significantly improves metabolic control in Type 2 diabetic patients poorly controlled with oral hypoglycaemic agents. This effect seems not to be a result of concomitant involuntary dietary changes, since acarbose did not induce modifications in diet during the study.
RCT Entities:
AIMS: It has been speculated that acarbose treatment in patients with Type 2 diabetes mellitus might induce changes in diet as a result of its adverse gastrointestinal effects. The aim of this study was to determine whether poor metabolic control can be improved by acarbose, and whether this might be because the acarbose supplementation provokes changes in diet. METHODS: Poorly controlled Type 2 diabeticpatients treated with oral hypoglycaemic agents (OHA) were randomized into either acarbose (100 mg t.d.s.) or placebo treatment. The double-blind treatment lasted for 24 weeks. Four-day food diaries and blood samples for efficacy analysis were collected at 0, 4, 12, and 24 weeks. Thirty-six acarbose and 39 placebo-treated patients completed the trial and were included in the final analyses. RESULTS: At 24 weeks the baseline adjusted means of fasting, 1 and 2-h postprandial blood glucose values were 9.3 vs. 10.5 (P=0.02), 11.6 vs. 14.5 (P<0.001) and 11.0 vs. 13.7 mmol/l (P<0.001) and HbA1 9.3% vs. 10.2% (P=0.002) in the acarbose and placebo groups, respectively. No significant differences in nutrient intakes between groups were observed. The energy intake and energy proportion of fat and carbohydrates remained unchanged in both groups. CONCLUSIONS:Acarbose significantly improves metabolic control in Type 2 diabeticpatients poorly controlled with oral hypoglycaemic agents. This effect seems not to be a result of concomitant involuntary dietary changes, since acarbose did not induce modifications in diet during the study.
Authors: Eberhard Standl; Michael J Theodorakis; Michael Erbach; Oliver Schnell; Jaakko Tuomilehto Journal: Cardiovasc Diabetol Date: 2014-04-16 Impact factor: 9.951