View Clinical Trial (Medical Research Study)
Comparison Of Endotoxin Concentration And Intestinal Microbiologic Flora Before And After Roux-En-Y Gastric Bypass Or Gastric Banding Surgery In Morbidly Obese Patients With Type 2 Diabetes Mellitus
| City: |
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Buffalo |
| State: |
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New York |
| 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.
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| 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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| NCT ID: |
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NCT00960765 |
| Primary Contact: |
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Principal Investigator
Joseph A Caruana, M.D.
Synergy Bariatrics
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| Backup Contact: |
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N/A |
| Location Contact: |
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Buffalo, New York 14214
United States
Joseph Caruana, MD
Phone: 716-565-3990
Email: jcaruanamd@synergybariatrics.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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