NCT01244971

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2010

Completed
Last Updated

November 22, 2010

Status Verified

December 1, 2003

Enrollment Period

5 months

First QC Date

November 19, 2010

Last Update Submit

November 19, 2010

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

  • Glycemic control

    Glycated A1c

    12 weeks

Study Arms (3)

Acarbose

ACTIVE COMPARATOR
Drug: Acarbose

Exercise

ACTIVE COMPARATOR
Behavioral: Exercise

Exercise + Acarbose

EXPERIMENTAL
Other: Exercise + Acarbose

Interventions

AcarboseDRUG

100mg, 3 times daily

Acarbose
ExerciseBEHAVIORAL

Moderate combined exercise, 50 minutes 3 times per week

Exercise
Exercise + AcarboseOTHER

See respective monotherapy description

Exercise + Acarbose

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Enheten för Metabol Kontroll, Endokrinkliniken, Karolinska University Hospital

Stockholm, Stockholm County, 17176, Sweden

Location

Related Publications (1)

  • Wagner H, Degerblad M, Thorell A, Nygren J, Stahle A, Kuhl J, Brismar TB, Ohrvik J, Efendic S, Bavenholm PN. Combined treatment with exercise training and acarbose improves metabolic control and cardiovascular risk factor profile in subjects with mild type 2 diabetes. Diabetes Care. 2006 Jul;29(7):1471-7. doi: 10.2337/dc05-2513.

    PMID: 16801564RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

AcarboseExercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TrisaccharidesOligosaccharidesPolysaccharidesCarbohydratesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Suad Efendic, Professor

    Dpt of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 19, 2010

First Posted

November 22, 2010

Study Start

January 1, 2004

Primary Completion

June 1, 2004

Last Updated

November 22, 2010

Record last verified: 2003-12

Locations

SE(1)