NCT06408961 EVOC - EVs in Obesity and Cardiometabolic Disease
| NCT ID | NCT06408961 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Cardiovascular Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2019-02-02 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2019-02-02 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Saumya Das, MD, PhD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT06408961 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06408961 currently recruiting?
Yes, NCT06408961 is actively recruiting participants. Contact the research team at SDAS@mgh.harvard.edu for enrollment information.
Where is the NCT06408961 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06408961 clinical trial?
NCT06408961 is sponsored by Massachusetts General Hospital. The principal investigator is Saumya Das, MD, PhD at Massachusetts General Hospital. The trial plans to enroll 100 participants.