EVOC - EVs in Obesity and Cardiometabolic Disease

This observational study, called EVOC, is looking into how tiny sacs released from cells, called Extracellular Vesicles (EVs), affect heart and metabolic health in people with obesity. Researchers want to understand what's inside the EVs from fat tissue and how these contents might impact your heart and liver function. They're also curious if changes in these EV contents are linked to better heart health and fat reduction after weight loss. You might be able to join if you are 18 or older and have obesity (BMI of 30 or more). Some participants will also need to have pre-diabetes or diabetes. The study aims to enroll 100 participants.

Study design
This is an observational study involving 100 participants. It is not specified if it is randomized or blinded.
What's involved
If you participate, samples of fat tissue and blood will be collected during gastric bypass weight loss surgery. Your medical history and records will also be followed.
Compensation
Not stated in the trial record.
Follow-up
Your medical history and records will be followed for 2 years to assess the impact of EV contents on cardiac and liver function, and changes related to weight loss.

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NCT06408961

EVOC - EVs in Obesity and Cardiometabolic Disease

Recruiting
Not specifiedAges 18+Observational
Massachusetts General Hospital
~100 participants
Updated 2026-06-17 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
What are the contents inside of fat (adipose) tissue derived Extracellular Vesicles (EVs)?
Measured over 2 years
+2 more outcomes measured
Cardiovascular Diseases
1 sites across 1 states
Massachusetts1
  • Saumya Das, MD, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

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Eligibility criteria

Inclusion

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

Pregnancy (as adjudicated by patient history)
Prior clinical history of myocardial infarction or valvular heart disease
  • What are the contents inside of fat (adipose) tissue derived Extracellular Vesicles (EVs)?2 years

    The study staff aim to obtain EVs from fat samples obtained at the time of bariatric weight loss surgery. The activity of genes within the cargo of the collected EVs are assessed using RNA sequencing and protein contents analysis. A statistical analysis performed utilizing computer technology will provide us with differentially expressed cargo that may be a step in the molecular communication pathway to the heart and liver tissues.

  • How does the contents of Extracellular Vesicles (EVs) impact cardiac and liver function?2 years

    The study will look at the functional role of EVs from visceral and subcutaneous fat tissue on 3D organ on chip (liver on chip) and the heart's muscle cells (cardiomyocytes) using microscopes, gene expression and an assessment of the cardiomyocyte's electrical properties. It is predicted that changes in the recipient cell's gene expression will correlate with the contents discovered in Outcome 1.

  • Are changes in Extracellular Vesicle (EV) content related to cardiac function and adiposity with weight loss?2 years

    EVs collected from fat tissue are present in blood and provide a minimally invasive method to determine the fat cell's activity for turning food to into energy. We aim to assess how the content of EVs collected from plasma within the blood, and the content related to fat tissue EVs from Objective 1 change with weight loss.