Overview

This trial is active, not recruiting.

Conditions overweight, insulin resistance, diabetes mellitus, type 2
Treatment exercise
Sponsor University of Copenhagen
Collaborator UNIK - Food, Fitness & Pharma
Start date September 2009
End date June 2011
Trial size 64 participants
Trial identifier NCT01430143, FourINonE

Summary

The aim of the study is to 1) delineate the molecular mechanisms behind the large variation in insulin sensitivity among apparently healthy subjects and to 2) establish the dose-response relationship between physical training and a) metabolic health, b) appetite and c) cultural health.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Exercise combusting 600 kcal/day, 7 days/week for 12 weeks.
exercise
Daily exercise for 12 weeks.
(Experimental)
Exercise combusting 300 kcal/day, 7 days/week for 12 weeks.
exercise
Daily exercise for 12 weeks.
(No Intervention)
Continued sedentary living.
exercise
Daily exercise for 12 weeks.

Primary Outcomes

Measure
Change from baseline in insulin sensitivity at 12 weeks
time frame: At baseline and 12 weeks

Secondary Outcomes

Measure
Change from baseline in body composition af 2, 6 and 12 weeks
time frame: At baseline, 2, 6 and 12 weeks
Change from baseline in appetite at 12 weeks
time frame: At baseline and 12 weeks
Motivational factors for exercise
time frame: During and for up to 1½ year after the intervention
Diameter of t-tubuli in skeletal muscle
time frame: At baseline

Eligibility Criteria

Male participants from 20 years up to 40 years old.

Inclusion Criteria: - Healthy according to interview - Caucasian - Sedentary, Vo2max < 45 ml/kg/min - BMI 25-30 kg/m2 - Fat percentage 25% < - Weight stable (+/- 2 kg within past 6 months) Exclusion Criteria: - First degree relatives with type 2 diabetes - Hemoglobin concentration < 8 mmol/l - Fasting plasma glucose 6.1 mmol/l < - Blood pressure 140/90 mmHg < - Regular intake of medicine

Additional Information

Official title Physical Activity for a Long and Healthy Life - Project FINE
Trial information was received from ClinicalTrials.gov and was last updated in September 2011.
Information provided to ClinicalTrials.gov by University of Copenhagen.