An interventional study of Exercise in Obesity, Weight Gain and Bariatric Surgery Candidate, sponsored by Joslin Diabetes Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by Joslin Diabetes Center · Not applicable, Interventional, and Basic science
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 15 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Joslin Diabetes Center is the lead sponsor of 80 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Exercise
High Intensity Exercise
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.
Changes in appetitive behavior.
Subjects will be evaluated with Three Factor Eating Questionnaire (TFEQ).
Time frame: 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.
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.
Changes in circulating exosome miRNAs will be measured using next-generation sequencing (NGS) and reported as normalized counts or fold changes relative to baseline.
Time frame: Evaluation of changes in miRNA before and after 12 weeks of exercise training.
Changes in cognitive function.
Evaluation using mini cognitive test.
Time frame: Changes in cognition function before and after 12 weeks of HIIT.
Plan to share: No
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