MedPath

Effects of Acarbose on Endothelial Function After a Mixed Meal in Newly Diagnosed Type 2 Diabetes

Phase 3
Completed
Conditions
Type 2 Diabetes
Interventions
Drug: placebo
Registration Number
NCT00551954
Lead Sponsor
Technische Universität Dresden
Brief Summary

Endothelial dysfunction (ED) has been suggested as a possible causal link between postprandial hyperglycemia and cardiovascular events in patients with type 2 diabetes. Recent trials demonstrated a reduction of cardiovascular events by treatment with the alpha glucosidase inhibitor acarbose - a drug which mainly reduces postprandial glucose excursions. We were interested whether patients with newly diagnosed type 2 diabetes showed postprandial ED and if so whether acarbose was able to improve this condition.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • age 35-75 years
  • type 2 diabetes (newly diagnosed)
  • well glycemic control (HbA1c </= 8.1)
  • leucocyte count > 6.2 or hs CrP > 1
Exclusion Criteria
  • hs CrP > 10
  • type 1 diabetes
  • previous treatment with antidiabetic drugs

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1acarbose20 weeks of treatment with acarbose (100 mg t.i.d.)
2placebo20 weeks of treatment with placebo (one tablet t.i.d.)
Primary Outcome Measures
NameTimeMethod
forearm blood flow assessed by forearm occlusion plethysmography after a mixed mealat baseline and after 20 weeks of treatment
Secondary Outcome Measures
NameTimeMethod
forearm blood flow assessed by forearm occlusion plethysmography in the fasting state, plasma glucose excursion in response to the mixed meal, insulin levels in response to the mixed meal, triglyceride levels in response to the mixed mealat baseline and after 20 weeks of treatment
© Copyright 2025. All Rights Reserved by MedPath