Assessment of Insulin Resistance, NAFLD, Predictors of CV Morbidity, and Subcutaneous Adipose and Visceral Adipose Gene Expression in Patients Undergoing Gastric Bypass Surgery - NCT01007955-01655(Clinical Trial 399529)
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| City: |
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Worcester |
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State:
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MA |
| Zip Code: |
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01655 |
| Conditions: |
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Morbid Obesity - Insulin Resistance - Non-Alcoholic Fatty Liver Disease |
| Purpose: |
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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.
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| Study summary: |
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Obesity is associated with insulin resistance and diabetes. Since both of these conditions
have been implicated in cardiovascular complications, this association may explain obesity
related illnesses and deaths. Gastric bypass is considered the "gold standard" surgical
weightloss procedure and has been demonstrated to cure diabetes and insulin resistance.
Some severely obese patients, however, have normal insulin-glucose metabolism. The
differences in metabolic healthy in severely obese individuals has not been fully recognized
or understood. This research will study insulin-glucose metabolism in a population of
severely obese individuals undergoing gastric bypass. This investigation is based on the
following hypotheses:
1. Severely obese individuals can be categorized by degree to which insulin-glucose
homeostasis is impaired.
2. The degree of insulin resistance correlates with risk for cardiovascular disease.
Weight loss in obese individuals with insulin resistance, will correlate with
improvement in parameters associated with cardiovascular disease. Obese individuals
with better insulin sensitivity will not have a high risk for cardiovascular disease
and therefore will not experience this risk reduction in cardiovascular disease.
3. Insulin resistance is a consequence of pathological storage of excess energy intake;
therefore, individuals who are insulin resistant and obese will differ from individuals
who are obese, but not insulin resistant with regards to gene expression in
subcutaneous adipose tissue and visceral adipose tissue.
Subjects will be studied for evidence of end organ dysfunction and predictors of morbidity
and mortality preoperatively and postoperatively. Additionally, gene expression in the
subcutaneous and visceral adipose depots of subjects will be studied |
| Criteria: |
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Inclusion Criteria:
- Morbid Obesity
- Scheduled to undergo gastric bypass surgery
Exclusion Criteria:
- Pregnancy (would not be candidate for surgery)
- Nursing (would not be candidate for surgery) |
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| Study is available at: |
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UMass Memorial Medical Center
Worcester, MA 01655
United States
Primary Contact:
Richard A Perugini, MD
Phone: 774-443-0432
Secondary Contact:
Karen A Gallagher-Dorval, RN
Email: karen.gallagher-dorval@umassmed.edu
Phone: 508-856-7559 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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