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: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

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.)

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
    

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

Lead Sponsor: Dresden University of Technology

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on August 29, 2008

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