Exercise and Acarbose in Type 2 Diabetes

Sponsor

Karolinska Institutet (Other)

Overall Status

Completed

CT.gov ID

NCT01244971

Collaborator

The Swedish Research Council (Other), Bayer (Industry)

Enrollment

Location

Arms

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Jan 1, 2004

Actual Primary Completion Date :

Jun 1, 2004

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Glycemic control [12 weeks]
Glycated A1c

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 60 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Enheten för Metabol Kontroll, Endokrinkliniken, Karolinska University Hospital	Stockholm		Sweden	17176

Sponsors and Collaborators

Karolinska Institutet
The Swedish Research Council
Bayer

Investigators

Study Chair: Suad Efendic, Professor, Dpt of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01244971

Other Study ID Numbers:

DNR 03-539

First Posted:

Nov 22, 2010

Last Update Posted:

Nov 22, 2010

Last Verified:

Dec 1, 2003

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Acarbose

Study Results

No Results Posted as of Nov 22, 2010