Cardiovascular DiseasesEVOCNCT06408961
EVOC - EVs in Obesity and Cardiometabolic Disease
An observational study of Cardiovascular Diseases, run by Massachusetts General Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2019to 1 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- Pregnancy (as adjudicated by patient history)
- Prior clinical history of myocardial infarction or valvular heart disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696
Clinical Research Coordinator, 617-643-9621, cazzam@mgh.harvard.edu
Saumya Das, MD/PhD
About this study
Official title: Extracellular Vesicle Signaling in Obesity and Cardiometabolic Disease (EVOC)
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:
- What molecular cargo do adipose-tissue EVs carry?
- How do these cargo impact cardiac and hepatic function?
- 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.
Read the detailed description
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
- Cardiovascular Diseases
- Keywords
- Extracellular Vesicles, Cardiometabolic Disease, Cardiovascular Risk, Type II Diabetes
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bariatric Surgery | Patients undergoing bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 years
Secondary outcomes (1)
How does the presence of diabetes or pre-diabetes alter the RNA content of Extracellular Vesicles?
The fat samples will be categorized based on the presence of diabetes, pre-diabetes and no diabetes of the subject at the time of weight loss surgery.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start2 Feb 2019
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Saumya Das, Massachusetts General Hospital
- Investigators
- Saumya Das, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408961
- Sponsor's protocol ID
- 2022P002665
- Acronym
- EVOC
- Status last verified
- Jun 2026
- First submitted
- 7 May 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40669467
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracellular Vesicle Signaling in Obesity and Cardiometabolic Disease (EVOC)
- ClinicalTrials.gov ID
- NCT06408961
- Acronym / sponsor ID
- EVOC / 2022P002665
- Conditions
- Cardiovascular Diseases
- Keywords
- Extracellular Vesicles, Cardiometabolic Disease, Cardiovascular Risk, Type II Diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What molecular cargo do adipose-tissue EVs carry?
- How do these cargo impact cardiac and hepatic function?
- 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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bariatric Surgery | – | –Patients undergoing bariatric surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- Pregnancy (as adjudicated by patient history)
- Prior clinical history of myocardial infarction or valvular heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
What are the contents inside of fat (adipose) tissue derived Extracellular Vesicles (EVs)?
Time frame: 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?
Time frame: 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?
Time frame: 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.
1 secondary outcome
How does the presence of diabetes or pre-diabetes alter the RNA content of Extracellular Vesicles?
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Results publication: PubMed 40669467Chatterjee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saumya Das, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saumya Das, MD, PhD (617-724-4500, SDAS@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
What are the contents inside of fat (adipose) tissue derived Extracellular Vesicles (EVs)? (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06408961, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.