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Exercise and Acarbose in Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01244971
First Posted: November 22, 2010
Last Update Posted: November 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The Swedish Medical Research Council
Bayer
Information provided by:
Karolinska Institutet
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Glycemic control [ Time Frame: 12 weeks ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

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

  Contacts and Locations
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): 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
First Submitted: November 19, 2010
First Posted: November 22, 2010
Last Update Posted: November 22, 2010
Last Verified: December 2003

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
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