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

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ClinicalTrials.gov Identifier: NCT00551954
Recruitment Status : Completed
First Posted : November 1, 2007
Last Update Posted : March 1, 2013
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden

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

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : July 2006
Actual Primary Completion Date : July 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Acarbose

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.




Primary Outcome Measures :
  1. forearm blood flow assessed by forearm occlusion plethysmography after a mixed meal [ Time Frame: at baseline and after 20 weeks of treatment ]

Secondary Outcome Measures :
  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 [ Time Frame: at baseline and after 20 weeks of treatment ]


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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00551954


Sponsors and Collaborators
Technische Universität Dresden
Investigators
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Principal Investigator: Markolf Hanefeld, PhD Center for Clinical Studies, Fiedlerstr. 34, 01307 Dresden, Germany

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Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT00551954     History of Changes
Other Study ID Numbers: AIDA a4
First Posted: November 1, 2007    Key Record Dates
Last Update Posted: March 1, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Acarbose
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs