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

NCT ID: NCT00551954

Last Updated: 2013-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Brief Summary

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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 newly diagnosed type 2 diabetes showed postprandial ED and if so whether acarbose was able to improve this condition.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

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

Group Type EXPERIMENTAL

acarbose

Intervention Type DRUG

100 mg (tablets) t.i.d.

2

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

one tablet t.i.d.

Interventions

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acarbose

100 mg (tablets) t.i.d.

Intervention Type DRUG

placebo

one tablet t.i.d.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Markolf Hanefeld, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Clinical Studies, Fiedlerstr. 34, 01307 Dresden, Germany

Other Identifiers

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AIDA a4

Identifier Type: -

Identifier Source: org_study_id

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