NCT00365495

Brief Summary

Physical activity as treatment for patients with type 2 diabetes (T2D). Treatment of T2D is often done by medication, changing the diet and increased physical activity. It is well established that physical training has a positive effect on the pathology of T2D such as increased insulin sensitivity and reduced fasting plasma glucose (7) and blood lipids (15). It is also well known that in healthy subjects endurance training increases mitochondrial density, lipid oxidation during submaximal exercise, and results in a number of qualitative changes in the control of OXPHOS (24). However, the effect of physical training on the mitochondrial function in skeletal muscle of patients with T2D has not been investigated. The purpose of this project is to investigate the effect of physical training on the mitochondrial respiratory function in muscles of patients with T2D. Skeletal muscle biopsies will be taken before and after 10 weeks of physical training in patients with T2D and matched control subjects. Mitochondria will be isolated from the muscle biopsies, and respiratory function, free radical production and UCP3 will be determined. Furthermore, measures of maximal oxygen consumption (VO2max), heart rate and capillary lactate concentrations and carbohydrate and lipid oxidation will be determined partly to verify an increased aerobic capacity and partly to investigate the changes in these factors in T2D patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Aug 2006

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

April 4, 2007

Status Verified

April 1, 2007

First QC Date

August 15, 2006

Last Update Submit

April 3, 2007

Conditions

Keywords

Type 2 diabetesphysical trainingmitochondrial function

Outcome Measures

Primary Outcomes (1)

  • Mitochondrial respiratory measurements. The investigations are carried out by two rounds - one before Christmas and one after.

Secondary Outcomes (6)

  • VO2max

  • Lipid oxidation

  • muscle fiber type composition

  • muscle oxidative enzymes

  • mitochondrial-specific proteins (UCP3)

  • +1 more secondary outcomes

Interventions

Eligibility Criteria

Age40 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male,
  • BMI above 26,
  • Age between 40 and 65,
  • Living a sedentary lifestyle

You may not qualify if:

  • Women
  • BMI under 26
  • Age under 40 and over 65
  • Trained subjects Control subjects: relatives to type 2 diabetic patients, T2D trial subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern Denmark and Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Martin Mogensen, PhD student

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2006

First Posted

August 17, 2006

Study Start

August 1, 2006

Study Completion

June 1, 2007

Last Updated

April 4, 2007

Record last verified: 2007-04

Locations