- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01430143
Physical Activity for a Long and Healthy Life (FINE)
July 31, 2018 updated by: Bente Merete Stallknecht, University of Copenhagen
Physical Activity for a Long and Healthy Life - Project FINE
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Copenhagen, Denmark, DK-2200
- Department of Biomedical Sciences, The University of Copenhagen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 600 kcal/day
Exercise combusting 600 kcal/day, 7 days/week for 12 weeks.
|
Daily exercise for 12 weeks.
|
Experimental: 300 kcal/day
Exercise combusting 300 kcal/day, 7 days/week for 12 weeks.
|
Daily exercise for 12 weeks.
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No Intervention: Sedentary
Continued sedentary living.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in body composition af 2, 6 and 12 weeks
Time Frame: At baseline, 2, 6 and 12 weeks
|
As measured by DEXA- and MRI-scanning.
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At baseline, 2, 6 and 12 weeks
|
Change from baseline in appetite at 12 weeks
Time Frame: At baseline and 12 weeks
|
As measured by food records, controlled diets, meal tests and appetite hormones
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At baseline and 12 weeks
|
Motivational factors for exercise
Time Frame: During and for up to 1½ year after the intervention
|
Ethnographic field work
|
During and for up to 1½ year after the intervention
|
Diameter of t-tubuli in skeletal muscle
Time Frame: At baseline
|
As measured in skeletal muscle biopsies by electron and confocal microscopy
|
At baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
September 1, 2011
First Submitted That Met QC Criteria
September 6, 2011
First Posted (Estimate)
September 7, 2011
Study Record Updates
Last Update Posted (Actual)
August 2, 2018
Last Update Submitted That Met QC Criteria
July 31, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FourINonE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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