Exercise and Acarbose in Type 2 Diabetes

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. Identifier: NCT01244971
Recruitment Status : Completed
First Posted : November 22, 2010
Last Update Posted : November 22, 2010
The Swedish Medical Research Council
Information provided by:
Karolinska Institutet

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Acarbose Behavioral: Exercise Other: Exercise + Acarbose Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
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.
Study Start Date : January 2004
Primary Completion Date : June 2004

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Glycemic control [ Time Frame: 12 weeks ]
    Glycated A1c

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

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

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 identifier (NCT number): NCT01244971

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

Publications of Results: Identifier: NCT01244971     History of Changes
Other Study ID Numbers: DNR 03-539
First Posted: November 22, 2010    Key Record Dates
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
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs