Overweight and ObesityNCT04195061
Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity
An observational study of Overweight and Obesity and Insulin Resistance, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this research study is to learn more about the hormones that muscles make during exercise, and if those hormones are associated with type 2 diabetes risk in adults who are overweight or obese. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Insulin Resistance
- What is being tested?
- Cardiopulmonary exercise test (CPET)
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2019to 17 Nov 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with overweight or obesity
Who may be able to join
- Previously enrolled in protocol 2004P000013 or protocol 2012P002276, which had overweight or obesity as inclusion criteria
- Ability to walk up 3 flights of stairs and 3 city blocks (to ensure ability to complete exercise testing)
Who cannot join
- Unstable heart or lung disease
- Exercise >150 minutes/week
- Participation in college sports
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The goal of this research study is to learn more about the hormones that muscles make during exercise, and if those hormones are associated with type 2 diabetes risk in adults who are overweight or obese. Participants will undergo exercise testing on an upright bicycle, with blood samples taken for muscle hormones before and after exercise. The hypothesis is that adults with overweight/obesity and insulin resistance will have an impaired muscle hormone profile in response to exercise compared to adults with overweight/obesity who are not insulin resistant.
- Conditions
- Overweight and Obesity, Insulin Resistance
- Being tested
- Cardiopulmonary exercise test (CPET)
- Medical subject headings
- Overweight, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary exercise test (CPET)Procedure or surgery
CPET studies will be performed in the Cardiovascular Performance Program exercise lab at MGH. Subjects will undergo CPET on an upright cycle ergometer with continual measurement of metabolic gas exchange via a commercially available metabolic cart as well as heart rate and blood pressure. Exercise will proceed according to a maximal effort clinical protocol. Subjects will then undergo a standardized 30-min work load on the upright cycle ergometer based on the results of the maximal effort clinical protocol.
| Study group | Role | What they receive |
|---|---|---|
| Cardiopulmonary exercise testing | Not described Receives: Procedure: Cardiopulmonary exercise test (CPET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Serum Myostatin Levels From Pre- to 3 Hours Post-exercise
Percent change in serum myostatin levels from pre- to 3 hours post-cardiopulmonary exercise test
Measured: Pre- to 3 hours post-exercise
Secondary outcomes (2)
Percent Change in Serum Myostatin Levels From Pre- to 2 Hours Post-exercise
Percent change in serum myostatin levels from pre- to 2 hours post-cardiopulmonary exercise test
Measured: Pre- to 2 hours post-exercise
Percent Change in Serum Myostatin Levels From Immediately Post to 2 Hours Post-exercise
Percent change in serum myostatin levels from immediately post to 2 hours post-cardiopulmonary exercise test
Measured: Immediately post to 2 hours post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start12 Dec 2019
- Primary completion17 Nov 2021
- Study completion17 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melanie Schorr Haines, M.D, Massachusetts General Hospital
- Investigators
- Melanie S Haines, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195061
- Sponsor's protocol ID
- 2017P001495
- Status last verified
- Jan 2024
- First submitted
- 9 Dec 2019
- Last updated
- 30 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity
- ClinicalTrials.gov ID
- NCT04195061
- Acronym / sponsor ID
- 2017P001495
- Conditions
- Overweight and Obesity, Insulin Resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 17 Nov 2021 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Posted 30 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research study is to learn more about the hormones that muscles make during exercise, and if those hormones are associated with type 2 diabetes risk in adults who are overweight or obese. Participants will undergo exercise testing on an upright bicycle, with blood samples taken for muscle hormones before and after exercise. The hypothesis is that adults with overweight/obesity and insulin resistance will have an impaired muscle hormone profile in response to exercise compared to adults with overweight/obesity who are not insulin resistant.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiopulmonary exercise testing | – | Procedure: Cardiopulmonary exercise test (CPET) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with overweight or obesity
Key inclusion criteria (2 listed)
- Previously enrolled in protocol 2004P000013 or protocol 2012P002276, which had overweight or obesity as inclusion criteria
- Ability to walk up 3 flights of stairs and 3 city blocks (to ensure ability to complete exercise testing)
Key exclusion criteria (3 listed)
- Unstable heart or lung disease
- Exercise >150 minutes/week
- Participation in college sports
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 |
|---|---|---|
| Cardiopulmonary exercise test (CPET)CPET studies will be performed in the Cardiovascular Performance Program exercise lab at MGH. Subjects will undergo CPET on an upright cycle ergometer with continual measurement of metabolic gas exchange via a commercially available metabolic cart as well as heart rate and blood pressure. Exercise will proceed according to a maximal effort clinical protocol. Subjects will then undergo a standardized 30-min work load on the upright cycle ergometer based on the results of the maximal effort clinical protocol. | Procedure or surgery | Cardiopulmonary exercise testing |
Primary outcome
Percent Change in Serum Myostatin Levels From Pre- to 3 Hours Post-exercise
Time frame: Pre- to 3 hours post-exercise
Percent change in serum myostatin levels from pre- to 3 hours post-cardiopulmonary exercise test
2 secondary outcomes
Percent Change in Serum Myostatin Levels From Pre- to 2 Hours Post-exercise
Time frame: Pre- to 2 hours post-exercise
Percent Change in Serum Myostatin Levels From Immediately Post to 2 Hours Post-exercise
Time frame: Immediately post to 2 hours post-exercise
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Melanie S Haines, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity and Insulin Resistance, run by Massachusetts General Hospital 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 2 inclusion and 3 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 30 Jan 2024. 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?
Yes. Results are posted in the registry (first posted 30 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in Serum Myostatin Levels From Pre- to 3 Hours Post-exercise (time frame: Pre- to 3 hours post-exercise). 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 30 Jan 2024.