Endotoxin and Intestinal Flora Before and After Gastric Bypass or Banding in Diabetics - NCT00960765-14214 (Clinical Trial 306180)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy306180.aspx
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| City: |
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Buffalo |
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State:
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NY |
| Zip Code: |
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14214 |
| Conditions: |
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Obesity, Morbid - Diabetes Mellitus, Type 2 - Gastric Bypass |
| Purpose: |
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This research project is designed to investigate endotoxin (a toxin present in the wall of
certain kinds of bacteria) levels and the type of bacteria present in the intestine before
and after Roux-en-Y gastric bypass or gastric banding surgery in patients that meet the
classification for morbid obesity (body mass index >40 kg/m2) and type 2 diabetes. It is
known that the type of bacteria present in the intestines of normal weight and obese
individuals are different, and it is also known that people with obesity and type 2 diabetes
have higher levels of endotoxin. It has been shown that the bacteria change over the long
run after Roux-en-Y gastric bypass surgery, but the short-term effects are not known and the
endotoxin levels after this procedure have never been studied.
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| Study summary: |
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Evidence exists that (i) morbidly obese, T2D patients undergoing RYGB are highly likely to
resolve T2D symptoms or dramatically reduce oral and/or insulin requirements, (ii) metabolic
endotoxemia may incite the pathologic conditions of low-grade inflammation and subsequently
insulin resistance, obesity and T2D, (iii) significant intestinal microbiologic flora
differences exist between normal weight and obese/diabetic individuals, and (iv) RYGB alters
long-term intestinal microbiologic flora. Therefore, it is logical to evaluate short- and
long-term circulating endotoxin concentrations and intestinal microbiologic flora in context
with weight loss and restoration of euglycemia to expand our knowledge of the mechanism of
the benefits observed following RYGB. |
| Criteria: |
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Inclusion Criteria:
- Age > 18 years of age
- Morbid obesity (BMI > 40 kg/m2)
- Confirmed T2D diagnosis/date of onset
Exclusion Criteria:
- Age < 18 years of age
- BMI < 40 kg/m2
- Type 1 diabetes
- Chronic use of non-steroidal anti-inflammatory agents (NSAIDs)
- Chronic use of systemic corticosteroids
- Anticipated inability to maintain current statin, angiotensin converting enzyme
inhibitor (ACEI), or angiotensin receptor blocking agent (ARB) regimen |
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| Study is available at: |
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Sisters of Charity Hospital
Buffalo, NY 14214
United States
Primary Contact:
Joseph Caruana, MD
Email: jcaruanamd@synergybariatrics.com
Phone: 716-565-3990 |
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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 16, 2010 |
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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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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