Recruiting

HIIT

Sponsor:

Joslin Diabetes Center

Code:

NCT06511310

Conditions

Obesity

Weight Gain

Bariatric Surgery Candidate

Appetitive Behavior

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Exercise

Study Details

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.

Conditions

Obesity

Weight Gain

Bariatric Surgery Candidate

Appetitive Behavior

Study ID

NCT06511310

Start date

Sep 15, 2025

Status verified date

Aug, 2025

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Exercise Training

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.

Interventions

Exercise

High Intensity Exercise

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. ]

Central Contacts and Locations

Central contacts

Maria Vamvini, MD

617-309-2400Maria.Vamvini@joslin.harvard.edu

Laura Simpson, MS

617-735-3924laura.simpson@joslin.harvard.edu

Locations

Joslin Diabetes Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Simpson

617-735-3924laura.simpson@joslin.harvard.edu

More Information

Sponsor

Joslin Diabetes Center

Last update posted

Sep 4, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Joslin Diabetes Center on 2025-09-04.