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NCT Number: NCT06511310

Exercise, Brain Activity, and Weight Maintenance

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

High Intensity Exercise

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes in appetitive behavior.

    Time frame: Evaluation of changes in hunger before and after 12 weeks of exercise training.

    Subjects will be evaluated with Three Factor Eating Questionnaire (TFEQ).

  2. Changes in mood.

    Time frame: Evaluation of changes in mood before and after 12 weeks of exercise training.

    Subjects will be evaluated with Beck Depression Inventory II (BDI-II) to assess for depressive symptoms.

  3. Degree of changes in miRNA profiling of circulating exosomes in blood samples.

    Time frame: Evaluation of changes in miRNA before and after 12 weeks of exercise training.

    Changes in circulating exosome miRNAs will be measured using next-generation sequencing (NGS) and reported as normalized counts or fold changes relative to baseline.

  4. Changes in cognitive function.

    Time frame: Changes in cognition function before and after 12 weeks of HIIT.

    Evaluation using mini cognitive test.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Simpson, MS

CONTACT

[email protected]

617-735-3924

Maria Vamvini, MD

CONTACT

[email protected]

617-309-2400

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

  • Nutrition Obesity Research Center

Registry information

Official study title

Effects of Exercise Training on Brain Activity and Its Relation to Weight Maintenance and Appetite Regulation

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 19, 2024
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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