NCT00551954

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.

Trial Health

100
On Track

Trial Health Score

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Status
completed

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2007

Completed
Last Updated

March 1, 2013

Status Verified

February 1, 2013

Enrollment Period

1 year

First QC Date

October 31, 2007

Last Update Submit

February 28, 2013

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

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

    at baseline and after 20 weeks of treatment

Secondary Outcomes (1)

  • 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

Study Arms (2)

1

EXPERIMENTAL

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

Drug: acarbose

2

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

acarboseDRUG

100 mg (tablets) t.i.d.

1
placeboDRUG

one tablet t.i.d.

2

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 35-75 years
  • type 2 diabetes (newly diagnosed)
  • well glycemic control (HbA1c \</= 8.1)
  • leucocyte count \> 6.2 or hs CrP \> 1

You may not qualify if:

  • hs CrP \> 10
  • type 1 diabetes
  • previous treatment with antidiabetic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Acarbose

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TrisaccharidesOligosaccharidesPolysaccharidesCarbohydrates

Study Officials

  • Markolf Hanefeld, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2007

First Posted

November 1, 2007

Study Start

July 1, 2006

Primary Completion

July 1, 2007

Last Updated

March 1, 2013

Record last verified: 2013-02