EVOC - EVs in Obesity and Cardiometabolic Disease
ConditionCardiovascular Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Pregnancy (as adjudicated by patient history)
Prior clinical history of myocardial infarction or valvular heart disease
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Bariatric Surgery
Trial outcomes
Primary outcomes
1
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.
Time frame
2 years2
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.
Time frame
2 years3
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.
Time frame
2 yearsSecondary 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.
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
American Heart Association
Collaborator
Source ClinicalTrials.gov