Clinical trial

EVOC - EVs in Obesity and Cardiometabolic Disease

Recruiting now · Not applicable · 1 countries · Registry ID NCT06408961

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionCardiovascular Diseases

Full registry 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

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Massachusetts General Hospital🇺🇸 Boston, Massachusetts, United States

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Clinical Research CoordinatorContact

Email · Call 617-643-9621

Saumya Das, MD/PhDPrincipal Investigator