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EVOC - EVs in Obesity and Cardiometabolic Disease

NCT ID: NCT06408961

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-02

Study Completion Date

2026-05-30

Brief Summary

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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.

Detailed Description

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The primary clinical objective of this research is to study the impact of molecular signals from the adipose tissue to the heart, liver and brain on cardiovascular disease risk in obesity, Type II Diabetes and other metabolic 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 hypothesis is that EVs derived from metabolically active fat tissue located around the abdominal organs (visceral adipose tissue) have a different cargo than those derived from non-metabolically active fat tissue located directly under the skin (subcutaneous adipose tissue), and that these cargoes impact the function of other organs. Further, we hypothesize that visceral adipose EVs are also present in the plasma in circulation, and that the content changes as patients become metabolically healthy following bariatric surgery.

After obtaining patient consent, samples from visceral fat tissue, subcutaneous fat tissue and blood will be collected during the gastric bypass weight loss surgery. These samples will be brought to lab where they will be processed for EVs. Subject's medical history and records will be followed as well. An optional, secondary blood draw may be collected 3 month post-surgery or within 24 months.

Following collection, the samples will be brough to the laboratory of the PI for processing. Samples will undergo characterization for proteins, extracellular or exosomal RNAs, tissue RNAs (e.g., leukocyte/buffy coat), and/or metabolites. A trascriptomic and proteomic analysis will be performed to determine differences in protein and RNA expression. The EVs will be extracted from subcutaneous and visceral fat tissue and used to treat heart muscle cells and liver-on-chip cells that have been produced in a laboratory setting.

Conditions

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Cardiovascular Diseases

Keywords

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Extracellular Vesicles Cardiometabolic Disease Cardiovascular Risk Type II Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bariatric Surgery

Patients undergoing bariatric surgery

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Saumya Das

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saumya Das, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Saumya Das, MD, PhD

Role: CONTACT

Phone: 617-724-4500

Email: [email protected]

Facility Contacts

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Clinical Research Coordinator

Role: primary

References

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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.

Reference Type RESULT
PMID: 40669467 (View on PubMed)

Other Identifiers

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2022P002665

Identifier Type: -

Identifier Source: org_study_id