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

Sponsor

Technische Universität Dresden (Other)

Overall Status

Completed

CT.gov ID

NCT00551954

Collaborator

(none)

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: acarbose Drug: placebo	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 20 weeks of treatment with acarbose (100 mg t.i.d.)	Drug: acarbose 100 mg (tablets) t.i.d.
Placebo Comparator: 2 20 weeks of treatment with placebo (one tablet t.i.d.)	Drug: placebo one tablet t.i.d.

Arm

Intervention/Treatment

Experimental: 1

20 weeks of treatment with acarbose (100 mg t.i.d.)

Drug: acarbose

100 mg (tablets) t.i.d.

Placebo Comparator: 2

20 weeks of treatment with placebo (one tablet t.i.d.)

Drug: placebo

one tablet t.i.d.

Outcome Measures

Primary Outcome Measures

forearm blood flow assessed by forearm occlusion plethysmography after a mixed meal [at baseline and after 20 weeks of treatment]

Secondary Outcome 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 [at baseline and after 20 weeks of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Technische Universität Dresden

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Technische Universität Dresden

ClinicalTrials.gov Identifier:

NCT00551954

Other Study ID Numbers:

AIDA a4

First Posted:

Nov 1, 2007

Last Update Posted:

Mar 1, 2013

Last Verified:

Feb 1, 2013

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Acarbose

Study Results

No Results Posted as of Mar 1, 2013