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

Verified by: Dresden University of Technology, October 2007
First Received: October 31, 2007 | Last Updated: October 31, 2007 | Phase: Phase 3 | Start Date: 
Overall Status: Completed |
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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...

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

  • Drug: acarbose
    • 100 mg (tablets) t.i.d.
  • Drug: placebo
    • one tablet t.i.d.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • 20 weeks of treatment with acarbose (100 mg t.i.d.)
  • Placebo Comparator: 2
    • 20 weeks of treatment with placebo (one tablet t.i.d.)

Outcome Measures for this Clinical Trial

Primary Measures

  • forearm blood flow assessed by forearm occlusion plethysmography after a mixed meal
    • Time Frame: at baseline and after 20 weeks of treatment

Secondary Measures

  • 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 meal
    • Time Frame: at baseline and after 20 weeks of treatment

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Dresden University of Technology Other

Overall Clinical Trial Officials and Contacts

Markolf Hanefeld, PhD Principal Investigator Center for Clinical Studies, Fiedlerstr. 34, 01307 Dresden, Germany  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00551954

Study ID Number: AIDA a4

ClinicalTrials.gov Identifier: NCT00551954

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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