Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408961
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-07
Brief Title:
EVOC - EVs in Obesity and Cardiometabolic Disease
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Extracellular Vesicle Signaling in Obesity and Cardiometabolic Disease EVOC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVOC
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 cells 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
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:
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 cells 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 Subjects 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 eg leukocytebuffy coat andor 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
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 Subjects 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 eg leukocytebuffy coat andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None