Exercise and Acarbose in Type 2 Diabetes

Diabetes Mellitus Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244971
• Other study ID #: DNR 03-539
• Status: Completed
• Phase: Phase 4
• First received: November 19, 2010
• Last updated: November 19, 2010
• Start date: January 2004

Study information

• Verified date: December 2003
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. primary completion date: June 2004
• Gender: Both
• Age group: 45 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Acarbose
100mg, 3 times daily

Behavioral:
• Exercise
Moderate combined exercise, 50 minutes 3 times per week

Other:
• Exercise + Acarbose
See respective monotherapy description

Locations

Country	Name	City	State
Sweden	Enheten för Metabol Kontroll, Endokrinkliniken, Karolinska University Hospital	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Bayer, The Swedish Medical Research Council

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Wagner H, Degerblad M, Thorell A, Nygren J, Ståhle A, Kuhl J, Brismar TB, Ohrvik J, Efendic S, Båvenholm PN. Combined treatment with exercise training and acarbose improves metabolic control and cardiovascular risk factor profile in subjects with mild typ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control	Glycated A1c	12 weeks	No