ObesityNCT02001142
Effect of Exercise on Metabolic Health
A study testing Exercise in people with Obesity, run by University of Michigan at 1 site in United States.
Trial summary
One of the main objectives of this study will be to assess potential differences in important risk factors associated with Metabolic Syndrome in overweight adults who do not participate in a regular exercise program compared with overweight individuals who do exercise regularly. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to 17 Sep 2016
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index [BMI] = 30-45 kg/m2, fasting blood glucose concentration must be < or = to125 mg/dl, Hematocrit > or = to 34%, all women must be pre-menopausal
Who cannot join
- pregnancy or actively breastfeeding, weight instability (> or = to ± 5 lbs in the past month) evidence of cardiovascular or metabolic diseases, taking medications know to affect lipid and/or glucose metabolism.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Clincal Research Unit
Ann Arbor, Michigan, 48109
About this study
Official title: Effect of Exercise on Novel Insulin Signaling Events in Human Muscle
One of the main objectives of this study will be to assess potential differences in important risk factors associated with Metabolic Syndrome in overweight adults who do not participate in a regular exercise program compared with overweight individuals who do exercise regularly. In addition, we will determine the effects of a single, modest session of exercise on the body's ability to control blood sugar and regulate fat metabolism in obese sedentary adults vs. obese adults who live a physically active lifestyle. Our study focuses on identifying mechanisms responsible for improved insulin action related to regular exercise and to provide novel targets for preventing and treating type 2 diabetes.
- Conditions
- Obesity
- Being tested
- Exercise
- Keywords
- Insulin Sensitivity, Exercise, Metabolism
- Medical subject headings
- Obesity, Insulin Resistance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
single session of exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Not described Receives: Other: Exercise |
| Sedentary Control | No intervention | Not described |
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. Insulin sensitivity will be calculated from the clamp data as the rate of glucose infusion during the steady state period of the clamp - divided by the plasma insulin concentration at this time (units: mg/uU/ml/min)
Measured: 2-3 hours
Secondary outcomes (2)
Resting Metabolic Rate
Measured: 20-30 min
Meal Tolerance Test
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startNov 2013
- Primary completion17 Sep 2016
- Study completion17 Sep 2016
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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, Jeffrey F Horowitz, University of Michigan
- Investigators
- Jeffrey F Horowitz, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001142
- Sponsor's protocol ID
- ADA 7-13-TS-35
- Status last verified
- Mar 2022
- First submitted
- 27 Nov 2013
- 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
- Effect of Exercise on Novel Insulin Signaling Events in Human Muscle
- ClinicalTrials.gov ID
- NCT02001142
- Acronym / sponsor ID
- ADA 7-13-TS-35
- Conditions
- Obesity
- Keywords
- Insulin Sensitivity, Exercise, Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Nov 2013
- Primary completion
- 17 Sep 2016 (actual)
- Study completion
- 17 Sep 2016 (actual)
- First posted
- 4 Dec 2013 (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.
One of the main objectives of this study will be to assess potential differences in important risk factors associated with Metabolic Syndrome in overweight adults who do not participate in a regular exercise program compared with overweight individuals who do exercise regularly. In addition, we will determine the effects of a single, modest session of exercise on the body's ability to control blood sugar and regulate fat metabolism in obese sedentary adults vs. obese adults who live a physically active lifestyle. Our study focuses on identifying mechanisms responsible for improved insulin action related to regular exercise and to provide novel targets for preventing and treating type 2 diabetes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: Exercise |
| Sedentary Control | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body Mass Index [BMI] = 30-45 kg/m2, fasting blood glucose concentration must be < or = to125 mg/dl, Hematocrit > or = to 34%, all women must be pre-menopausal
Key exclusion criteria (1 listed)
- pregnancy or actively breastfeeding, weight instability (> or = to ± 5 lbs in the past month) evidence of cardiovascular or metabolic diseases, taking medications know to affect lipid and/or glucose metabolism.
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 |
|---|---|---|
| Exercisesingle session of exercise | Other | Exercise |
Primary outcome
Insulin Sensitivity
Time frame: 2-3 hours
A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity. Insulin sensitivity will be calculated from the clamp data as the rate of glucose infusion during the steady state period of the clamp - divided by the plasma insulin concentration at this time (units: mg/uU/ml/min)
2 secondary outcomes
Resting Metabolic Rate
Time frame: 20-30 min
Meal Tolerance Test
Time frame: 3 hours
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, PhD 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 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.