Fat‑cell particles and cardiometabolic health in people having weight‑loss surgery
Extracellular Vesicle Signaling in Obesity and Cardiometabolic Disease (EVOC)
Massachusetts General Hospital · NCT06408961
This research sees if tiny packages released by belly and under‑skin fat carry different molecules that affect heart and liver function and change after bariatric weight‑loss surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06408961 on ClinicalTrials.gov |
What this trial studies
The study collects visceral and subcutaneous fat tissue and blood from adults undergoing bariatric (gastric bypass) surgery to isolate extracellular vesicles (EVs) and analyze their molecular cargo. Researchers will compare EV contents between visceral and subcutaneous fat, test effects on cardiac and hepatic function in laboratory assays, and look for the same visceral EV signatures in plasma. Clinical history and outcomes will be followed and an optional secondary blood draw may be collected around 3 months up to 24 months after surgery to track changes with weight loss. This observational approach aims to link EV molecular profiles with adiposity and measures of cardiometabolic health rather than test a treatment.
Who should consider this trial
Good fit: Adults (age ≥18) with obesity who are planning to undergo bariatric surgery, including a subset with prediabetes or diabetes, are the ideal candidates.
Not a fit: People who are not undergoing bariatric surgery, who are pregnant, or who have a prior myocardial infarction or valvular heart disease (excluded from participation) are unlikely to benefit from joining this protocol.
Why it matters
Potential benefit: If successful, the work could identify blood markers and molecular targets that predict or explain heart and metabolic improvements after weight loss.
How similar studies have performed: Prior basic and translational studies have shown that EVs carry metabolic and inflammatory signals linked to cardiometabolic disease, but clinical application of these findings remains early and exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age greater than or equal to 18 years of age * Obese (BMI\>/=30 kg/m2; for obesity/bariatric surgery group) * For 20 patients, additional criteria will be presence of pre-diabetes or diabetes (HgbA1c \> 5.7 or Fasting blood glucose \> 100). Exclusion Criteria: * Pregnancy (as adjudicated by patient history) * Prior clinical history of myocardial infarction or valvular heart disease
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Saumya Das, MD, PhD — Massachusetts General Hospital
- Study coordinator: Saumya Das, MD, PhD
- Email: SDAS@mgh.harvard.edu
- Phone: 617-724-4500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiovascular Diseases, Extracellular Vesicles, Cardiometabolic Disease, Cardiovascular Risk, Type II Diabetes