Exercise, Brain Activity, and Weight Maintenance Study

This study is looking at how high-intensity exercise (HIIT) affects brain function and pathways related to weight control. It aims to understand how exercise might help with weight management, especially for people who have regained weight after bariatric surgery. You might be able to join if you are between 18 and 70 years old, have a Body Mass Index (BMI) over 19 kg/m², and weigh less than 250kg. If you've had bariatric surgery, you must have regained more than 10% of your lost weight within 1 to 5 years after surgery. The study will measure changes in the connections between different brain areas using a special type of MRI (magnetic resonance imaging) called resting state functional MRI after 12 weeks of exercise training. The current status of this study is unclear.

Study design
This is an interventional study with 15 planned participants. It will involve a 12-week high-intensity interval training (HIIT) program.
What's involved
You will have three initial clinical visits, followed by a 12-week HIIT program with four weekly sessions, and then three post-training clinical visits. These visits include body measurements, blood draws, glucose tests, psychological evaluations, MRI screenings, metabolic rate assessments, VO₂peak tests, and functional MRIs.
Compensation
Not stated in the trial record.
Follow-up
Participants will repeat all baseline assessments after completing the 12-week exercise program.

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NCT06511310

Exercise, Brain Activity, and Weight Maintenance

Recruiting
NAAges 18–70InterventionalBasic science
Joslin Diabetes Center
~15 participants
Updated 2025-09-04 on ClinicalTrials.gov
What's tested:Exercise

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in connectivity between brain areas following exercise training by using resting state functional MRI.
Measured over Evaluation of changes in brain function by fMRI before and after 12 weeks of exercise training.
Obesity
Weight Gain
Bariatric Surgery Candidate
Appetitive Behavior
1 sites across 1 states
Massachusetts1
  • Maria Vamvini, MD · PRINCIPAL_INVESTIGATOR · Joslin Diabetes Center

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Eligibility criteria

Inclusion

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

Exclusion

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
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
  • Changes in connectivity between brain areas following exercise training by using resting state functional MRI.Evaluation of changes in brain function by fMRI before and after 12 weeks of exercise training.