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CompletedNCT01430143FINEUpdated Aug 2, 2018

Physical Activity for a Long and Healthy Life

An interventional study of Exercise in Overweight, Insulin Resistance and Diabetes Mellitus, Type 2, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-02.

Sponsored by University of Copenhagen · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Overweight
  • Insulin Resistance
  • Diabetes Mellitus, Type 2

Keywords

  • Exercise
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 64 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    600 kcal/day

    Exercise combusting 600 kcal/day, 7 days/week for 12 weeks.

    Behavioral: Exercise

  • Experimental
    300 kcal/day

    Exercise combusting 300 kcal/day, 7 days/week for 12 weeks.

    Behavioral: Exercise

  • No intervention
    Sedentary

    Continued sedentary living.

Interventions

  • BehavioralExercise

    Daily exercise for 12 weeks.

06

What researchers measure

Primary outcomes

  1. Change from baseline in insulin sensitivity at 12 weeks

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

    Time frame: At baseline and 12 weeks

Secondary outcomes

  1. Change from baseline in body composition af 2, 6 and 12 weeks

    As measured by DEXA- and MRI-scanning.

    Time frame: At baseline, 2, 6 and 12 weeks

  2. Change from baseline in appetite at 12 weeks

    As measured by food records, controlled diets, meal tests and appetite hormones

    Time frame: At baseline and 12 weeks

  3. Motivational factors for exercise

    Ethnographic field work

    Time frame: During and for up to 1½ year after the intervention

  4. Diameter of t-tubuli in skeletal muscle

    As measured in skeletal muscle biopsies by electron and confocal microscopy

    Time frame: At baseline

07

Study locations

1 site
  • Department of Biomedical Sciences, The University of Copenhagen
    Copenhagen, DK-2200, Denmark
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01430143
Lead sponsor
University of Copenhagen
Collaborators
Universitetssenteret på Kjeller, Center for Healthy Aging, The Novo Nordic Foundation, Copenhagen University Hospital, Denmark, Glostrup University Hospital, Copenhagen
Responsible party
Bente Merete Stallknecht (Associate professor, University of Copenhagen) — Principal investigator
First posted
Sep 7, 2011
Start date
Sep 2009
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Aug 2, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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