Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT06408961

Conditions

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The goal of this observational study is to research the impact of molecular signals from the heart, liver and fat tissue on cardiovascular disease risk, and the presentation of Type II Diabetes and diseases that affect the heart, blood vessels and metabolism (Cardiometabolic Disease). Specifically, the focus is on the content and function of Extracellular Vesicles (EVs), small sacs released from a cell's surface that contain important molecular cargo. The main questions it aims to answer are:

1. What molecular cargo do adipose-tissue EVs carry?
2. How do these cargo impact cardiac and hepatic function?
3. Are changes in EV content related to cardiac function and adiposity with weight loss?

Tissue samples from fat tissue and blood samples will be collected from patients receiving bariatric weight loss surgery.

Conditions

Cardiovascular Diseases

Study ID

NCT06408961

Start date

Feb 2, 2019

Status verified date

Jun, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Bariatric Surgery

Patients undergoing bariatric surgery

Primary outcome measure

  • What are the contents inside of fat (adipose) tissue derived Extracellular Vesicles (EVs)? [ Time Frame: 2 years ]
  • How does the contents of Extracellular Vesicles (EVs) impact cardiac and liver function? [ Time Frame: 2 years ]
  • Are changes in Extracellular Vesicle (EV) content related to cardiac function and adiposity with weight loss? [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Saumya Das, MD, PhD

617-724-4500SDAS@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114-2696

Contacts

Clinical Research Coordinator

617-643-9621cazzam@mgh.harvard.edu

Principal Investigator:

Saumya Das, MD/PhD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

  • Extracellular Vesicles
  • Cardiometabolic Disease
  • Cardiovascular Risk
  • Type II Diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-06-17.