ObesityNCT01452074
Progressive Metabolic Adaptations to Low Intensity Exercise Training and Weight Loss
A study testing Exercise Training and Weight Loss with continued Exercise Training in people with Obesity, run by University of Michigan at 1 site in United States.
Trial summary
the investigators first aim is to determine the effect of low intensity exercise (without weight loss) on insulin sensitivity, muscle lipid metabolism, and factors regulating these processes in skeletal muscle after 1 day, 2 wks, 12 wks of training, and again after 3 days without exercise in obese adults. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Exercise Training and Weight Loss with continued Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to 18 Jul 2014
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- body mass index [BMI]: 30-45 kg/m2; All women must be pre-menopausal; Non-exerciser (no regularly planned exercise/physical activity)
Who cannot join
- Hematocrit ≤ 34%; Fasting plasma glucose concentration ≥ 125 mg/dL; Weight instability ≥ ±5 lbs in past month; Taking medications known to affect lipid and/or glucose metabolism; evidence and/or history of cardiovascular or frank metabolic diseases; pregnancy or actively breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Clincal Research Unit
Ann Arbor, Michigan, 48109
About this study
the investigators first aim is to determine the effect of low intensity exercise (without weight loss) on insulin sensitivity, muscle lipid metabolism, and factors regulating these processes in skeletal muscle after 1 day, 2 wks, 12 wks of training, and again after 3 days without exercise in obese adults. the investigators second aim is to determine the effect of combining low intensity exercise training with 10% weight loss on insulin sensitivity, muscle lipid metabolism, and factors regulating these processes in skeletal muscle.
Although a single 40 minute session of exercise at a low exercise intensity will not improve insulin sensitivity, the investigators anticipate adaptations after two weeks of exercise training (6 session/wk; 12 session total) will improve insulin sensitivity and be accompanied by a reduction in fatty acid intermediates and a reduction in markers for pro-inflammatory activation in muscle. the investigators anticipate changes in insulin sensitivity, fatty acid partitioning, and pro-inflammatory markers the day after the last session of a 12 wk training program (without weight-loss) will be similar to that measured after 2 weeks of training. the investigators anticipate insulin sensitivity, accumulation of fatty acid intermediates, and pro-inflammatory activation will be markedly improved after 10% weight loss when measured the day after exercise. the investigators would expect the improvements in Insulin sensitivity, accumulation of fatty acid intermediates, and markers of inflammatory stress will be significantly attenuated when measured 3 days after the most recent exercise session, but beneficial effects of 10% weight loss on these metabolic endpoints will persist when compared with before weight loss.
- Conditions
- Obesity
- Being tested
- Exercise Training, Weight Loss with continued Exercise Training
- Keywords
- Insulin Sensitivity, Exercise Training, Weight Loss, Fat Metabolism
- Medical subject headings
- Obesity, Insulin Resistance, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingOther
During the first 12 weeks of the study, subjects will adhere to an exercise training program while maintaining their original body weight. The exercise training program will entail the following: 40min/session, ~50% of their maximal aerobic capacity (approximately 100-110 beats per min), 5-6 days/week
Weight Loss with continued Exercise TrainingOther
After the first 12 weeks in the study, subjects will continue with the same exercise program, but then they will be placed on a reduced calorie diet until they lose exactly 10% of their original body weight
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training with Weight Loss | Other | During the first 12 weeks of the study, subjects will adhere to an exercise training program while maintaining their original body weight. The exercise training program will entail the following: 40min/session, ~50% of their maximal aerobic capacity (approximately 100-110 beats per min), 5-6 days/week
After the first 12 weeks in the study, subjects will continue with the same exercise program, but then they will be placed on a reduced calorie diet until they lose exactly 10% of their original body weight Receives: Other: Exercise Training; Other: Weight Loss with continued Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity
Measured: 2-3 hours
Secondary outcomes (2)
Resting Metabolic Rate
Measured: 20-30 min
Meal Tolerance Test
Measured: 2-3h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startJul 2011
- Primary completion18 Jul 2014
- Study completion18 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey F Horowitz, University of Michigan
- Investigators
- Jeffrey F Horowitz, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452074
- Sponsor's protocol ID
- R01 DK077966 - PA
- Other IDs
- R01DK077966
- Status last verified
- Mar 2022
- First submitted
- 11 Oct 2011
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Metabolic Adaptations to Low Intensity Exercise Training and Weight Loss
- ClinicalTrials.gov ID
- NCT01452074
- Acronym / sponsor ID
- R01 DK077966 - PA
- Conditions
- Obesity
- Keywords
- Insulin Sensitivity, Exercise Training, Weight Loss, Fat Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2011
- Primary completion
- 18 Jul 2014 (actual)
- Study completion
- 18 Jul 2014 (actual)
- First posted
- 14 Oct 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 investigators first aim is to determine the effect of low intensity exercise (without weight loss) on insulin sensitivity, muscle lipid metabolism, and factors regulating these processes in skeletal muscle after 1 day, 2 wks, 12 wks of training, and again after 3 days without exercise in obese adults. the investigators second aim is to determine the effect of combining low intensity exercise training with 10% weight loss on insulin sensitivity, muscle lipid metabolism, and factors regulating these processes in skeletal muscle.
Although a single 40 minute session of exercise at a low exercise intensity will not improve insulin sensitivity, the investigators anticipate adaptations after two weeks of exercise training (6 session/wk; 12 session total) will improve insulin sensitivity and be accompanied by a reduction in fatty acid intermediates and a reduction in markers for pro-inflammatory activation in muscle. the investigators anticipate changes in insulin sensitivity, fatty acid partitioning, and pro-inflammatory markers the day after the last session of a 12 wk training program (without weight-loss) will be similar to that measured after 2 weeks of training. the investigators anticipate insulin sensitivity, accumulation of fatty acid intermediates, and pro-inflammatory activation will be markedly improved after 10% weight loss when measured the day after exercise. the investigators would expect the improvements in Insulin sensitivity, accumulation of fatty acid intermediates, and markers of inflammatory stress will be significantly attenuated when measured 3 days after the most recent exercise session, but beneficial effects of 10% weight loss on these metabolic endpoints will persist when compared with before weight loss.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Training with Weight Loss | Other | Other: Exercise Training, Other: Weight Loss with continued Exercise TrainingDuring the first 12 weeks of the study, subjects will adhere to an exercise training program while maintaining their original body weight. The exercise training program will entail the following: 40min/session, ~50% of their maximal aerobic capacity (approximately 100-110 beats per min), 5-6 days/week After the first 12 weeks in the study, subjects will continue with the same exercise program, but then they will be placed on a reduced calorie diet until they lose exactly 10% of their original body weight |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- body mass index [BMI]: 30-45 kg/m2; All women must be pre-menopausal; Non-exerciser (no regularly planned exercise/physical activity)
Key exclusion criteria (1 listed)
- Hematocrit ≤ 34%; Fasting plasma glucose concentration ≥ 125 mg/dL; Weight instability ≥ ±5 lbs in past month; Taking medications known to affect lipid and/or glucose metabolism; evidence and/or history of cardiovascular or frank metabolic diseases; pregnancy or actively breast feeding
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 |
|---|---|---|
| Exercise TrainingDuring the first 12 weeks of the study, subjects will adhere to an exercise training program while maintaining their original body weight. The exercise training program will entail the following: 40min/session, ~50% of their maximal aerobic capacity (approximately 100-110 beats per min), 5-6 days/week | Other | Exercise Training with Weight Loss |
| Weight Loss with continued Exercise TrainingAfter the first 12 weeks in the study, subjects will continue with the same exercise program, but then they will be placed on a reduced calorie diet until they lose exactly 10% of their original body weight | Other | Exercise Training with Weight Loss |
Primary outcome
Insulin Sensitivity
Time frame: 2-3 hours
A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity
2 secondary outcomes
Resting Metabolic Rate
Time frame: 20-30 min
Meal Tolerance Test
Time frame: 2-3h
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 21 Mar 2022.
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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.
Jeffrey F Horowitz principal investigator
University of Michigan
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 Training and Weight Loss with continued Exercise Training in people with Obesity, run by University of Michigan at 1 site in United States.
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 1 inclusion and 1 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 21 Mar 2022. 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 United States. 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?
Insulin Sensitivity (time frame: 2-3 hours). 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 21 Mar 2022.