Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06408961 |
| Other study ID # |
2022P002665 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 5, 2023 |
| Est. completion date |
June 30, 2026 |
Study information
| Verified date |
May 2024 |
| Source |
Massachusetts General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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). 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.
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.
