NCT06511310 Exercise, Brain Activity, and Weight Maintenance
| NCT ID | NCT06511310 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Joslin Diabetes Center |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2025-09-15 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Maria Vamvini, MD
PRINCIPAL INVESTIGATOR
Joslin Diabetes Center
Frequently Asked Questions
Who can join the NCT06511310 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06511310 currently recruiting?
Yes, NCT06511310 is actively recruiting participants. Contact the research team at Maria.Vamvini@joslin.harvard.edu for enrollment information.
Where is the NCT06511310 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06511310 clinical trial?
NCT06511310 is sponsored by Joslin Diabetes Center. The principal investigator is Maria Vamvini, MD at Joslin Diabetes Center. The trial plans to enroll 15 participants.
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