Back to resultsPhysical Activity for a Long and Healthy Life (FINE)
Primary Purpose
Overweight, Insulin Resistance, Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional basic science trial for Overweight focused on measuring Exercise
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
Sites / Locations
- Department of Biomedical Sciences, The University of Copenhagen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
600 kcal/day
300 kcal/day
Sedentary
Arm Description
Exercise combusting 600 kcal/day, 7 days/week for 12 weeks.
Exercise combusting 300 kcal/day, 7 days/week for 12 weeks.
Continued sedentary living.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change from baseline in body composition af 2, 6 and 12 weeks
As measured by DEXA- and MRI-scanning.
Change from baseline in appetite at 12 weeks
As measured by food records, controlled diets, meal tests and appetite hormones
Motivational factors for exercise
Ethnographic field work
Diameter of t-tubuli in skeletal muscle
As measured in skeletal muscle biopsies by electron and confocal microscopy
Full Information
NCT ID
NCT01430143
First Posted
September 1, 2011
Last Updated
July 31, 2018
Sponsor
University of Copenhagen
Collaborators
Universitetssenteret på Kjeller, Center for Healthy Aging, The Novo Nordic Foundation, Copenhagen University Hospital, Denmark, Glostrup University Hospital, Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT01430143
Brief Title
Physical Activity for a Long and Healthy Life
Acronym
FINE
Official Title
Physical Activity for a Long and Healthy Life - Project FINE
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Universitetssenteret på Kjeller, Center for Healthy Aging, The Novo Nordic Foundation, Copenhagen University Hospital, Denmark, Glostrup University Hospital, Copenhagen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Insulin Resistance, Diabetes Mellitus, Type 2
Keywords
Exercise
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
600 kcal/day
Arm Type
Experimental
Arm Description
Exercise combusting 600 kcal/day, 7 days/week for 12 weeks.
Arm Title
300 kcal/day
Arm Type
Experimental
Arm Description
Exercise combusting 300 kcal/day, 7 days/week for 12 weeks.
Arm Title
Sedentary
Arm Type
No Intervention
Arm Description
Continued sedentary living.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Daily exercise for 12 weeks.
Primary Outcome Measure Information:
Title
Change from baseline in insulin sensitivity at 12 weeks
Description
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 Outcome Measure Information:
Title
Change from baseline in body composition af 2, 6 and 12 weeks
Description
As measured by DEXA- and MRI-scanning.
Time Frame
At baseline, 2, 6 and 12 weeks
Title
Change from baseline in appetite at 12 weeks
Description
As measured by food records, controlled diets, meal tests and appetite hormones
Time Frame
At baseline and 12 weeks
Title
Motivational factors for exercise
Description
Ethnographic field work
Time Frame
During and for up to 1½ year after the intervention
Title
Diameter of t-tubuli in skeletal muscle
Description
As measured in skeletal muscle biopsies by electron and confocal microscopy
Time Frame
At baseline
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Department of Biomedical Sciences, The University of Copenhagen
City
Copenhagen
ZIP/Postal Code
DK-2200
Country
Denmark
12. IPD Sharing Statement
Links:
URL
http://fine.ku.dk
Description
Click here for more information about this study: Physical Activity for a Long and Healthy Life
Learn more about this trial
Physical Activity for a Long and Healthy Life
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