Physical Activity for a Long and Healthy Life - Project FINE

University of Copenhagen1 site in 1 country64 target enrollmentSeptember 2009

ConditionsOverweight Insulin Resistance Diabetes Mellitus, Type 2

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Overweight
Sponsor: University of Copenhagen
Enrollment: 64
Locations: 1
Primary Endpoint: Change from baseline in insulin sensitivity at 12 weeks
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

June 2011

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

University of Copenhagen

Responsible Party

Principal Investigator

Bente Merete Stallknecht

Associate professor

University of Copenhagen

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change from baseline in insulin sensitivity at 12 weeks

Time Frame: At baseline and 12 weeks

As measured by a hyperinsulinemic, isoglycemic clamp combined with skeletal muscle and adipose tissue biopsies as well as low-dose PET/CT.

Secondary Outcomes

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