Exercise, Brain Activity, and Weight Maintenance
Launched by JOSLIN DIABETES CENTER · Jul 15, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how high-intensity interval training (HIIT), a type of exercise, affects brain function and pathways related to weight control. The goal is to better understand how exercise can help with maintaining weight, especially for people who have regained weight after having bariatric surgery. Researchers hope that this study will provide important insights for future treatments aimed at obesity.
To participate in this study, you need to be between 18 and 70 years old and have a body mass index (BMI) higher than 19. You should also have lost a significant amount of weight in the past but have since regained over 10% of that weight within 1 to 5 years after your bariatric surgery. Participants must be in generally good health and able to follow the study's requirements. You will undergo some tests, including brain scans (MRI), and be asked about your weight loss journey. However, certain health conditions and situations, such as pregnancy or recent heart problems, may prevent you from joining. If you're interested, this study could help pave the way for new ways to tackle weight gain after surgery.
Gender
ALL
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
About Joslin Diabetes Center
Joslin Diabetes Center is a leading research and clinical care institution dedicated to advancing the understanding and treatment of diabetes. Affiliated with Harvard Medical School, Joslin combines innovative research, education, and patient care to improve outcomes for individuals with diabetes. The center is recognized for its commitment to pioneering clinical trials that explore novel therapies and interventions, aiming to enhance the quality of life for patients. With a focus on translating scientific discoveries into practical solutions, Joslin Diabetes Center plays a pivotal role in shaping the future of diabetes care and management.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Maria Vamvini, MD
Principal Investigator
Joslin Diabetes Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported