Insulin SensitivityTPSNCT01090869
Physical Training Per se
A study testing 12 weeks of lifestyle change in people with Insulin Sensitivity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The investigators aimed to evaluate the health benefits of physical training per se, weight loss per se and exercise-induced weight loss in young, overweight men. The investigators hypothesized that physical training would have independent effects on various health parameters (insulin sensitivity, fasting glucose and… 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
- Insulin Sensitivity
- What is being tested?
- 12 weeks of lifestyle change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2007to Jun 2009
- 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
- Overweight (body mass index 25-30 kg/m2)
- Weight stable (±2 kg during the past 6 months)
- Body fat% >25%,
- Maximal oxygen uptake <45 mL/min/kg
- Sedentary and healthy according to interview
- Fasting glucose <6.1 mmol/L
- Blood pressure <140/90 mmHg
- No first degree relatives with type-2-diabetes
Who cannot join
- Resistance training
- Inability to meet intervention criteria
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Copenhagen, Faculty Of Health Sciences, Department of Biomedical Sciences
Copenhagen, 2200
About this study
Official title: Physical Activity is Healthy - Effect of Weight Loss or Physical Training Per se?
The investigators aimed to evaluate the health benefits of physical training per se, weight loss per se and exercise-induced weight loss in young, overweight men. The investigators hypothesized that physical training would have independent effects on various health parameters (insulin sensitivity, fasting glucose and insulin, total and abdominal fat mass, waist circumference, blood pressure and key muscle proteins), and that a concomitant weight loss from physical activity would increase the effect.
Read the detailed description
At baseline, during the intervention and in the week following the intervention participants underwent a panel of tests:
- Cardio respiratory fitness
- blood pressure
- anthropometric measures
At baseline and after the intervention a hyperinsulinemic, euglycemic clamp were performed to asses insulin sensitivity.
Tissue and blood samples were also collected for further analysis:
- Total-protein analysis of selected proteins
- Fasting plasma glucose, insulin and free fatty acids
- Conditions
- Insulin Sensitivity
- Being tested
- 12 weeks of lifestyle change
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 weeks of lifestyle changeBehavioural
Participants were randomly assigned to a 12-week intervention in one of four groups: Training (T), energy-reduced Diet (D), Training and increased- Diet (T-iD) or Control (C). The interventions consisted of: T: increased physical activity through daily endurance training equivalent to 600 kcal/day, unchanged diet; D: sedentary lifestyle, reduced diet by 600 kcal/day primarily through reducing serving sizes and substituting energy dense with less energy dense nutrients; T-iD: increased physical activity through daily endurance training equivalent to 600 kcal/day, increased diet by 600 kcal/day primarily through increasing serving sizes and consuming energy dense nutrients; C: sedentary lifestyle and unchanged diet.
| Study group | Role | What they receive |
|---|---|---|
| Physical training, unchanged diet | Active comparator | Daily endurance training equivalent to 600 kcal/day and unchanged habitual diet Receives: Behavioral: 12 weeks of lifestyle change |
| Physical training, increased diet | Active comparator | Daily endurance training equivalent to 600 kcal/day, and increased diet by 600 kcal/day. Receives: Behavioral: 12 weeks of lifestyle change |
| Diet, unchanged physical activity | Active comparator | Energy-reduced diet by 600 kcal/day, and unchanged sedentary lifestyle Receives: Behavioral: 12 weeks of lifestyle change |
| Control | No intervention | Unchanged sedentary lifestyle and diet Receives: Behavioral: 12 weeks of lifestyle change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin sensitivity
Before and after the 12 week interventions a 1-step, 120 min, hyperinsulinaemic, euglycemic clamp was performed. After an initial 2mL bolus of insulin infusate, insulin was infused at 40 microU/min/kg.
Measured: week 0 and 13
Secondary outcomes (1)
Changes in body composition
Before, during and after the 12-week interventions changes in: Body mass, Lean body mass, Fat mass, Abdominal fat mass, and Viceral and subcutaneous fat were assesed by DEXA and MRI scans.
Measured: DEXA: week 0, 2, 6, 10, and 13; MRI: Week 0 and 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2010 (estimated)
- Study startMar 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Pernille Nordby, MSc, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090869
- Sponsor's protocol ID
- H-KF-2006-6443
- Acronym
- TPS
- Status last verified
- Oct 2007
- First submitted
- 16 Mar 2010
- Last updated
- 23 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity is Healthy - Effect of Weight Loss or Physical Training Per se?
- ClinicalTrials.gov ID
- NCT01090869
- Acronym / sponsor ID
- TPS / H-KF-2006-6443
- Conditions
- Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 23 Mar 2010 (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 investigators aimed to evaluate the health benefits of physical training per se, weight loss per se and exercise-induced weight loss in young, overweight men. The investigators hypothesized that physical training would have independent effects on various health parameters (insulin sensitivity, fasting glucose and insulin, total and abdominal fat mass, waist circumference, blood pressure and key muscle proteins), and that a concomitant weight loss from physical activity would increase the effect.
Detailed description
At baseline, during the intervention and in the week following the intervention participants underwent a panel of tests:
- Cardio respiratory fitness
- blood pressure
- anthropometric measures
At baseline and after the intervention a hyperinsulinemic, euglycemic clamp were performed to asses insulin sensitivity.
Tissue and blood samples were also collected for further analysis:
- Total-protein analysis of selected proteins
- Fasting plasma glucose, insulin and free fatty acids
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Physical training, unchanged diet | Active comparator | Behavioral: 12 weeks of lifestyle changeDaily endurance training equivalent to 600 kcal/day and unchanged habitual diet |
| Physical training, increased diet | Active comparator | Behavioral: 12 weeks of lifestyle changeDaily endurance training equivalent to 600 kcal/day, and increased diet by 600 kcal/day. |
| Diet, unchanged physical activity | Active comparator | Behavioral: 12 weeks of lifestyle changeEnergy-reduced diet by 600 kcal/day, and unchanged sedentary lifestyle |
| Control | No intervention | Behavioral: 12 weeks of lifestyle changeUnchanged sedentary lifestyle and diet |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Overweight (body mass index 25-30 kg/m2)
- Weight stable (±2 kg during the past 6 months)
- Body fat% >25%,
- Maximal oxygen uptake <45 mL/min/kg
- Sedentary and healthy according to interview
Key exclusion criteria (2 listed)
- Resistance training
- Inability to meet intervention criteria
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 |
|---|---|---|
| 12 weeks of lifestyle changeParticipants were randomly assigned to a 12-week intervention in one of four groups: Training (T), energy-reduced Diet (D), Training and increased- Diet (T-iD) or Control (C). The interventions consisted of: T: increased physical activity through daily endurance training equivalent to 600 kcal/day, unchanged diet; D: sedentary lifestyle, reduced diet by 600 kcal/day primarily through reducing serving sizes and substituting energy dense with less energy dense nutrients; T-iD: increased physical activity through daily endurance training equivalent to 600 kcal/day, increased diet by 600 kcal/day primarily through increasing serving sizes and consuming energy dense nutrients; C: sedentary lifestyle and unchanged diet. | Behavioural | Control, Diet, unchanged physical activity, Physical training, increased diet, Physical training, unchanged diet |
Primary outcome
Change in insulin sensitivity
Time frame: week 0 and 13
Before and after the 12 week interventions a 1-step, 120 min, hyperinsulinaemic, euglycemic clamp was performed. After an initial 2mL bolus of insulin infusate, insulin was infused at 40 microU/min/kg.
1 secondary outcome
Changes in body composition
Time frame: DEXA: week 0, 2, 6, 10, and 13; MRI: Week 0 and 13
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 23 Mar 2010.
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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.
Pernille Nordby, MSc principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12 weeks of lifestyle change in people with Insulin Sensitivity, 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 8 inclusion and 2 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 23 Mar 2010. 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 in insulin sensitivity (time frame: week 0 and 13). 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 23 Mar 2010.