ObesityNCT06511310
Exercise, Brain Activity, and Weight Maintenance
A study testing Exercise in people with Obesity and Weight Gain, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
This study aims to explore how HIIT influences brain function, neural and molecular pathways related to weight control, setting the stage for future obesity intervention research. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Gain, Bariatric Surgery Candidate
- 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
- 15 Sep 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age 18-70 years
- Body mass index (BMI) >19 kg/m2 and body weight< 250kg
- Participants must have experienced a clinically significant weight regain, defined as over 10% of their maximum weight lost, within 1 to 5 years following their bariatric surgery. They will be asked to self-report their weight loss history. Participants must also provide the operative report from their bariatric surgery for reference.
- In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations
- Willing to adhere to the protocol requirements for the duration of the study
Who cannot join
- Type 1 diabetes mellitus
- Peripheral neuropathy with insensate feet
- Recent blood donation within the last 2 months
- Use of beta-blockers
- Current pregnancy or breastfeeding
- Active Heart or lung disease
Show all 21Show fewer
- Severe hypertension (systolic >160 mmHg or diastolic >90 mmHg)
- Inability to exercise for any reason
- Any known contraindication to exercise testing based on current ACSM guidelines
- MRI contraindications, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body
- Known presence of a structural brain lesion (e.g. tumor, cortical infarct)
- Presence of another neurologic disorder, which could impact findings (e.g. multiple sclerosis)
- History of cardiovascular disease, stroke, congestive heart failure
- Active hematological, renal, pulmonary or hepatic disorders
- Active treatment for cancer
- A history of active alcohol or substance abuse
- Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol
- History of claustrophobia and inability to tolerate an MRI
- Body weight >250kgr and largest body diameter of 70cm as there is a certain weight and diameter limit of the MRI scanner
- Unwilling or unable to return for study visits, undergo neuropsychological testing and MRI imaging
- Left-handedness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Joslin Diabetes Center
Boston, Massachusetts, 02215
Simpson, 617-735-3924, laura.simpson@joslin.harvard.edu
About this study
Official title: Effects of Exercise Training on Brain Activity and Its Relation to Weight Maintenance and Appetite Regulation
This study aims to explore how HIIT influences brain function, neural and molecular pathways related to weight control, setting the stage for future obesity intervention research.
Read the detailed description
This study will include adults aged 18-70 years with a BMI >19 kg/m², both with and without prior bariatric surgery. Those with bariatric surgery must have experienced clinically significant weight regain (>10% of maximum weight lost) within 1 to 5 years post-surgery.
Participants will complete three initial clinical visits before beginning a 12-week high-intensity interval training (HIIT) program, followed by three post-training clinical visits. During visit 1, participants will undergo anthropometric assessments, baseline blood draw, oral glucose tolerance test, psychometric evaluations, and complete an MRI safety screening. At visit 2, participants will complete a resting metabolic rate assessment and a VO₂peak test. During visit 3, participants will have another baseline blood draw and undergo a functional MRI (fMRI).
The HIIT program will consist of four weekly 28-minute sessions conducted at the Joslin Diabetes and at home. Each exercise session will include a 3-minute warm-up, six rounds of 40 seconds high-intensity followed by 3 minutes of moderate intensity, and will conclude with a 3-minute cool-down.
After completing the 12-week program, participants will return for clinical visits 4-6, repeating all baseline assessments.
- Conditions
- Obesity, Weight Gain, Bariatric Surgery Candidate, Appetitive Behavior
- Being tested
- Exercise
- Medical subject headings
- Obesity, Weight Gain, Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
High Intensity Exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training | Experimental | Subjects will complete a supervised high-intensity interval training program for 12 weeks, including four weekly training sessions. The training session will include a 3 minute warm-up followed by six 40 second bouts of high intensity (85-95% of VO2peak) with 3 minutes moderate intensity (45-55% of VO2peak) between each bout of high intensity, concluding with a 3 minute cool-down. Each participant's target heart rate will be specific to them, calculated from the exercise test completed during Visit 1. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in connectivity between brain areas following exercise training by using resting state functional MRI.
Measured: Evaluation of changes in brain function by fMRI before and after 12 weeks of exercise training.
Secondary outcomes (4)
Changes in appetitive behavior.
Subjects will be evaluated with Three Factor Eating Questionnaire (TFEQ).
Measured: Evaluation of changes in hunger before and after 12 weeks of exercise training.
Changes in mood.
Subjects will be evaluated with Beck Depression Inventory II (BDI-II) to assess for depressive symptoms.
Measured: Evaluation of changes in mood before and after 12 weeks of exercise training.
Degree of changes in miRNA profiling of circulating exosomes in blood samples.
Changes in circulating exosome miRNAs will be measured using next-generation sequencing (NGS) and reported as normalized counts or fold changes relative to baseline.
Measured: Evaluation of changes in miRNA before and after 12 weeks of exercise training.
Changes in cognitive function.
Evaluation using mini cognitive test.
Measured: Changes in cognition function before and after 12 weeks of HIIT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start15 Sep 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
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.
- 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nutrition Obesity Research Center
- Responsible party
- Sponsor
- Investigators
- Maria Vamvini, MD, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511310
- Sponsor's protocol ID
- 00000256
- Status last verified
- Aug 2025
- First submitted
- 18 Jun 2024
- Last updated
- 4 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Training on Brain Activity and Its Relation to Weight Maintenance and Appetite Regulation
- ClinicalTrials.gov ID
- NCT06511310
- Acronym / sponsor ID
- 00000256
- Conditions
- Obesity, Weight Gain, Bariatric Surgery Candidate, Appetitive Behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- Nutrition Obesity Research Center
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 19 Jul 2024 (actual)
- 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.
This study aims to explore how HIIT influences brain function, neural and molecular pathways related to weight control, setting the stage for future obesity intervention research.
Detailed description
This study will include adults aged 18-70 years with a BMI >19 kg/m², both with and without prior bariatric surgery. Those with bariatric surgery must have experienced clinically significant weight regain (>10% of maximum weight lost) within 1 to 5 years post-surgery.
Participants will complete three initial clinical visits before beginning a 12-week high-intensity interval training (HIIT) program, followed by three post-training clinical visits. During visit 1, participants will undergo anthropometric assessments, baseline blood draw, oral glucose tolerance test, psychometric evaluations, and complete an MRI safety screening. At visit 2, participants will complete a resting metabolic rate assessment and a VO₂peak test. During visit 3, participants will have another baseline blood draw and undergo a functional MRI (fMRI).
The HIIT program will consist of four weekly 28-minute sessions conducted at the Joslin Diabetes and at home. Each exercise session will include a 3-minute warm-up, six rounds of 40 seconds high-intensity followed by 3 minutes of moderate intensity, and will conclude with a 3-minute cool-down.
After completing the 12-week program, participants will return for clinical visits 4-6, repeating all baseline assessments.
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 | Experimental | Other: ExerciseSubjects will complete a supervised high-intensity interval training program for 12 weeks, including four weekly training sessions. The training session will include a 3 minute warm-up followed by six 40 second bouts of high intensity (85-95% of VO2peak) with 3 minutes moderate intensity (45-55% of VO2peak) between each bout of high intensity, concluding with a 3 minute cool-down. Each participant's target heart rate will be specific to them, calculated from the exercise test completed during Visit 1. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-70 years
- Body mass index (BMI) >19 kg/m2 and body weight< 250kg
- Participants must have experienced a clinically significant weight regain, defined as over 10% of their maximum weight lost, within 1 to 5 years following their bariatric surgery. They will be asked to self-report their weight loss history. Participants must also provide the operative report from their bariatric surgery for reference.
- In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations
- Willing to adhere to the protocol requirements for the duration of the study
Key exclusion criteria (21 listed)
- Type 1 diabetes mellitus
- Peripheral neuropathy with insensate feet
- Recent blood donation within the last 2 months
- Use of beta-blockers
- Current pregnancy or breastfeeding
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 |
|---|---|---|
| ExerciseHigh Intensity Exercise | Other | Exercise Training |
Primary outcome
Changes in connectivity between brain areas following exercise training by using resting state functional MRI.
Time frame: Evaluation of changes in brain function by fMRI before and after 12 weeks of exercise training.
4 secondary outcomes
Changes in appetitive behavior.
Time frame: Evaluation of changes in hunger before and after 12 weeks of exercise training.
Changes in mood.
Time frame: Evaluation of changes in mood before and after 12 weeks of exercise training.
Degree of changes in miRNA profiling of circulating exosomes in blood samples.
Time frame: Evaluation of changes in miRNA before and after 12 weeks of exercise training.
Changes in cognitive function.
Time frame: Changes in cognition function before and after 12 weeks of HIIT.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Maria Vamvini, MD principal investigator
Joslin Diabetes Center
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 and Weight Gain, run by Joslin Diabetes Center 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 5 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 4 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Vamvini, MD (617-309-2400, Maria.Vamvini@joslin.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in connectivity between brain areas following exercise training by using resting state functional MRI. (time frame: Evaluation of changes in brain function by fMRI before and after 12 weeks of exercise training.). 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 4 Sep 2025.