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

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00551954
• Other study ID #: AIDA a4
• Status: Completed
• Phase: Phase 3
• First received: October 31, 2007
• Last updated: February 28, 2013
• Start date: July 2006

Study information

• Verified date: February 2013
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	forearm blood flow assessed by forearm occlusion plethysmography after a mixed meal		at baseline and after 20 weeks of treatment
Secondary	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		at baseline and after 20 weeks of treatment