OverweightFINENCT01430143
Physical Activity for a Long and Healthy Life
A study testing Exercise in people with Overweight and Insulin Resistance, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Insulin Resistance, Diabetes Mellitus, Type 2
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Biomedical Sciences, The University of Copenhagen
Copenhagen, DK-2200
About this study
Official title: 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.
- Conditions
- Overweight, Insulin Resistance, Diabetes Mellitus, Type 2
- Being tested
- Exercise
- Keywords
- Exercise
- Medical subject headings
- Overweight, Insulin Resistance, Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Daily exercise for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 600 kcal/day | Experimental | Exercise combusting 600 kcal/day, 7 days/week for 12 weeks. Receives: Behavioral: Exercise |
| 300 kcal/day | Experimental | Exercise combusting 300 kcal/day, 7 days/week for 12 weeks. Receives: Behavioral: Exercise |
| Sedentary | No intervention | Continued sedentary living. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and 12 weeks
Secondary outcomes (4)
Change from baseline in body composition af 2, 6 and 12 weeks
As measured by DEXA- and MRI-scanning.
Measured: At baseline, 2, 6 and 12 weeks
Change from baseline in appetite at 12 weeks
As measured by food records, controlled diets, meal tests and appetite hormones
Measured: At baseline and 12 weeks
Motivational factors for exercise
Ethnographic field work
Measured: During and for up to 1½ year after the intervention
Diameter of t-tubuli in skeletal muscle
As measured in skeletal muscle biopsies by electron and confocal microscopy
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startSep 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Universitetssenteret på Kjeller, Center for Healthy Aging, The Novo Nordic Foundation, Copenhagen University Hospital, Denmark, Glostrup University Hospital, Copenhagen
- Responsible party
- Principal investigator, Bente Merete Stallknecht, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430143
- Sponsor's protocol ID
- FourINonE
- Acronym
- FINE
- Status last verified
- Jul 2018
- First submitted
- 1 Sep 2011
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity for a Long and Healthy Life - Project FINE
- ClinicalTrials.gov ID
- NCT01430143
- Acronym / sponsor ID
- FINE / FourINonE
- Conditions
- Overweight, Insulin Resistance, Diabetes Mellitus, Type 2
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Universitetssenteret på Kjeller, Center for Healthy Aging, The Novo Nordic Foundation, Copenhagen University Hospital, Denmark, Glostrup University Hospital, Copenhagen
- Study start
- Sep 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 600 kcal/day | Experimental | Behavioral: ExerciseExercise combusting 600 kcal/day, 7 days/week for 12 weeks. |
| 300 kcal/day | Experimental | Behavioral: ExerciseExercise combusting 300 kcal/day, 7 days/week for 12 weeks. |
| Sedentary | No intervention | –Continued sedentary living. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy according to interview
- Caucasian
- Sedentary, Vo2max < 45 ml/kg/min
- BMI 25-30 kg/m2
- Fat percentage 25% <
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseDaily exercise for 12 weeks. | Behavioural | 300 kcal/day, 600 kcal/day |
Primary outcome
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.
4 secondary outcomes
Change from baseline in body composition af 2, 6 and 12 weeks
Time frame: At baseline, 2, 6 and 12 weeks
Change from baseline in appetite at 12 weeks
Time frame: At baseline and 12 weeks
Motivational factors for exercise
Time frame: During and for up to 1½ year after the intervention
Diameter of t-tubuli in skeletal muscle
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Click here for more information about this study: Physical Activity for a Long and Healthy LifeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Overweight and Insulin Resistance, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in insulin sensitivity at 12 weeks (time frame: At baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.