NCT06408961RECRUITINGN/A

EVOC - EVs in Obesity and Cardiometabolic Disease

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.

Sponsor

Massachusetts General Hospital

Enrollment

100 participants

Sites

1 locations

Start Date

February 2019

Completion

May 2026

Cardiovascular Diseases

View on ClinicalTrials.gov

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.

Eligibility

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

The extracellular vesicle transcriptome provides tissue-specific functional genomic annotation relevant to disease susceptibility in obesity.

Chatterjee Emeli, Betti Michael J, Sheng Quanhu et al.Cell genomics2025

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Fetching protocol from ClinicalTrials.gov…

NCT06408961RECRUITINGN/A

EVOC - EVs in Obesity and Cardiometabolic Disease

Sponsor

Massachusetts General Hospital

Enrollment

100 participants

Sites

1 locations

Start Date

February 2019

Completion

May 2026

Cardiovascular Diseases

View on ClinicalTrials.gov

Primary Outcomes

What are the contents inside of fat (adipose) tissue derived Extracellular Vesicles (EVs)?

2 years

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

2 years

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

2 years

Eligibility

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

The extracellular vesicle transcriptome provides tissue-specific functional genomic annotation relevant to disease susceptibility in obesity.

Chatterjee Emeli, Betti Michael J, Sheng Quanhu et al.Cell genomics2025

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

EVOC - EVs in Obesity and Cardiometabolic Disease

Primary Outcomes

Eligibility

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

EVOC - EVs in Obesity and Cardiometabolic Disease

Primary Outcomes

Eligibility

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Trial Sites (1)