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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acarbose

Drug

100 mg (tablets) t.i.d.

Placebo

Drug

one tablet t.i.d.

Primary outcomes

forearm blood flow assessed by forearm occlusion plethysmography after a mixed meal

Time frame: at baseline and after 20 weeks of treatment

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Important dates

Study start: 2006
Primary completion: 2007
First posted: Nov 1, 2007
Registry last updated: Mar 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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