Physical Activity for a Long and Healthy Life
FINE
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 1, 2011
CompletedFirst Posted
Study publicly available on registry
September 7, 2011
CompletedAugust 2, 2018
July 1, 2018
1.7 years
September 1, 2011
July 31, 2018
Conditions
Keywords
Outcome Measures
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.
At baseline and 12 weeks
Secondary Outcomes (4)
Change from baseline in body composition af 2, 6 and 12 weeks
At baseline, 2, 6 and 12 weeks
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
Study Arms (3)
600 kcal/day
EXPERIMENTALExercise combusting 600 kcal/day, 7 days/week for 12 weeks.
300 kcal/day
EXPERIMENTALExercise combusting 300 kcal/day, 7 days/week for 12 weeks.
Sedentary
NO INTERVENTIONContinued sedentary living.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Copenhagenlead
- Universitetssenteret på Kjellercollaborator
- Center for Healthy Agingcollaborator
- The Novo Nordic Foundationcollaborator
- Copenhagen University Hospital, Denmarkcollaborator
- Glostrup University Hospital, Copenhagencollaborator
Study Sites (1)
Department of Biomedical Sciences, The University of Copenhagen
Copenhagen, DK-2200, Denmark
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
September 1, 2011
First Posted
September 7, 2011
Study Start
September 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
August 2, 2018
Record last verified: 2018-07