High-intensity interval exercise to support brain activity and weight maintenance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults aged 18–70 with BMI >19 kg/m², including people with prior bariatric surgery who have regained >10% of their maximum weight loss within 1–5 years, will complete three baseline visits with blood tests, metabolic and fitness testing, psychometric questionnaires, and an fMRI. Participants then follow a 12-week HIIT program with four 28-minute sessions per week performed both at the Joslin Diabetes Center and at home. After training, participants repeat the same clinical, metabolic, and imaging assessments to compare before-and-after changes in brain function, metabolic markers, and fitness. The protocol combines supervised and home-based exercise sessions and multimodal outcome measurements to link physiological and neural changes with weight-control behaviors.

Why it matters

Who can join: the full rules

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

Where it's running

• Joslin Diabetes Center
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Maria Vamvini, MD — Joslin Diabetes Center
• Study coordinator: Maria Vamvini, MD
• Email: Maria.Vamvini@joslin.harvard.edu
• Phone: 617-309-2400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.