EVOC - EVs in Obesity and Cardiometabolic Disease

NCT06408961 | Recruiting

• 1 other identifier: 2022P002665
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiovascular Diseases

Keywords

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

Outcome Measures

Primary Outcomes (3)

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

  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.

  2 years

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

  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.

  2 years

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

  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.

  2 years

Secondary Outcomes (1)

• How does the presence of diabetes or pre-diabetes alter the RNA content of Extracellular Vesicles?

  2 years

Study Arms (1)

Bariatric Surgery

Patients undergoing bariatric surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of 100 eligible subjects with obesity (BMI\>/=30 kg/m2) who are planned to undergo bariatric surgery recruited from the clinic of Dr. Denise Gee in the Weight Center at Massachusetts General Hospital.

You may qualify if:

• 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).

You may not qualify if:

• Pregnancy (as adjudicated by patient history)
• Prior clinical history of myocardial infarction or valvular heart disease

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Heart Association: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114-2696, United States

RECRUITING

Related Publications (1)

• Chatterjee E, Betti MJ, Sheng Q, Lin P, Emont MP, Li G, Amancherla K, Garcia-Contreras M, Gokulnath P, Limpitikul WB, Whittaker OR, Luong K, Azzam C, Gee D, Hutter M, Flanders K, Sahu P, Flynn CR, Brown J, Yu D, Rosen ED, Van-Keuren Jensen K, Gamazon ER, Shah R, Das S. The extracellular vesicle transcriptome provides tissue-specific functional genomic annotation relevant to disease susceptibility in obesity. Cell Genom. 2025 Sep 10;5(9):100925. doi: 10.1016/j.xgen.2025.100925. Epub 2025 Jul 15.

  PMID: 40669467 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

The study will be collecting plasma, subcutaneous fat tissue and visceral fat tissue.

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Saumya Das, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saumya Das, MD, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: February 2, 2019
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)