Physical Activity for a Long and Healthy Life

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Insulin Resistance; Overweight
• Interventions: Behavioral: Exercise

• Registration Number: NCT01430143
• Lead Sponsor: University of Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Submitted: 2011-09-01
• Study First Submitted QC: 2011-09-06
• Study First Posted: 2011-09-07
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
600 kcal/day	Exercise	Exercise combusting 600 kcal/day, 7 days/week for 12 weeks.
300 kcal/day	Exercise	Exercise combusting 300 kcal/day, 7 days/week for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change from baseline in insulin sensitivity at 12 weeks	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 Outcome Measures

Name	Time	Method
Change from baseline in appetite at 12 weeks	At baseline and 12 weeks	As measured by food records, controlled diets, meal tests and appetite hormones
Motivational factors for exercise	During and for up to 1½ year after the intervention	Ethnographic field work
Diameter of t-tubuli in skeletal muscle	At baseline	As measured in skeletal muscle biopsies by electron and confocal microscopy
Change from baseline in body composition af 2, 6 and 12 weeks	At baseline, 2, 6 and 12 weeks	As measured by DEXA- and MRI-scanning.

Trial Locations

Locations (1)

Department of Biomedical Sciences, The University of Copenhagen; 🇩🇰 Copenhagen, Denmark