Assessment of Insulin Resistance, NAFLD, Predictors of CV Morbidity, and Subcutaneous Adipose and Visceral Adipose Gene Expression in Patients Undergoing Gastric Bypass Surgery
1 other identifier
observational
61
1 country
1
Brief Summary
The purpose of this research is to further study the effect weight loss after gastric bypass surgery has on the heart and blood pressure and on how the body uses or metabolizes the sugars, fats and proteins we eat. Additionally, the researchers want to study fat tissue for gene patterns which may be responsible for where we carry fat on our bodies, as well as look carefully at a possible link between adipose tissue and insulin resistance. The researchers also want to evaluate the liver for the presence of fatty liver, which is common in people with obesity and is associated with insulin resistance, as well as study the liver for gene patterns which may be associated with non-alcoholic liver disease. Evaluating cardiovascular function and endocrine function before and after gastric bypass surgery, as well as studying adipose and liver tissue may help us understand the link between obesity, insulin resistance, fatty liver disease, high blood pressure and health problems such as diabetes and heart disease. Consequently, this may help in the future by identifying those who will benefit most from gastric bypass surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2006
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 3, 2009
CompletedFirst Posted
Study publicly available on registry
November 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedAugust 24, 2012
August 1, 2012
5.5 years
November 3, 2009
August 23, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement of insulin resistance and/or diabetes
Two weeks postoperatively, Six months postoperatively, One year postoperatively
Secondary Outcomes (1)
Improvement of cardiovascular risk factors
Two weeks postoperatively, Six months postoperatively, One year postoperatively
Study Arms (1)
Severely Obese
Severely obese individuals scheduled to undergo gastric bypass surgery
Eligibility Criteria
Severely obese patients undergoing gastric bypass surgery
You may qualify if:
- Morbid Obesity
- Scheduled to undergo gastric bypass surgery
You may not qualify if:
- Pregnancy (would not be candidate for surgery)
- Nursing (would not be candidate for surgery)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Biospecimen
Subcutaneous and visceral adipose tissue.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 3, 2009
First Posted
November 5, 2009
Study Start
November 1, 2006
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
August 24, 2012
Record last verified: 2012-08