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Exercise and Acarbose in Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborators:
The Swedish Medical Research Council
Bayer
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01244971
First received: November 19, 2010
Last updated: NA
Last verified: December 2003
History: No changes posted
  Purpose

The purpose of this study is to investigate the impact of exercise training, Acarbose, and the combination of exercise and Acarbose on glycemic control, body composition, insulin sensitivity and other cardiovascular risk markers in type 2 diabetes. Further, muscle biopsies will be obtain to study gene expression. Our hypothesis is that the combination therapy will be superior to monotherapy with exercise or Acarbose.


Condition Intervention Phase
Diabetes Mellitus Type 2
 Drug: Acarbose
Behavioral: Exercise
Other: Exercise + Acarbose
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Exercise Training - Alone or in Combination With Acarbose - on Clinical and Metabolic Factors, and Studies of Cellular and Moleculargenetic Factors, in Type 2 Diabetes.

Resource links provided by NLM:

Drug Information available for: Acarbose
U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Glycemic control [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Glycated A1c


Enrollment: 62
Study Start Date: January 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acarbose Drug: Acarbose
100mg, 3 times daily
Active Comparator: Exercise Behavioral: Exercise
Moderate combined exercise, 50 minutes 3 times per week
Experimental: Exercise + Acarbose Other: Exercise + Acarbose
See respective monotherapy description

  Eligibility

Ages Eligible for Study:   45 Years to 60 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria: Men and women, diagnosis of type 2 diabetes established since at least three months, treatment with diet or maximum one oral anti-diabetic drug, GHb < 8.5 %, age 45 - 60 years, BMI 25 - 30 kg/m2, no participation in any regular exercise program.

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Exclusion Criteria: Unable to perform exercise, significant GI-disease, severe heart-disease, renal failure

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244971

Locations
Sweden
Enheten för Metabol Kontroll, Endokrinkliniken, Karolinska University Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet
The Swedish Medical Research Council
Bayer
Investigators
Study Chair: Suad Efendic, Professor Dpt of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT01244971     History of Changes
Other Study ID Numbers: DNR 03-539
Study First Received: November 19, 2010
Last Updated: November 19, 2010
Health Authority: Sweden: The National Board of Health and Welfare

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

ClinicalTrials.gov processed this record on May 23, 2013