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| Sponsor: | CPL Associates |
|---|---|
| Collaborators: |
Synergy Bariatrics Sisters of Charity Hospital NYS Center of Excellence in Bioinformatics & Life Sciences |
| Information provided by: | CPL Associates |
| ClinicalTrials.gov Identifier: | NCT00960765 |
Purpose
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.
| Condition |
|---|
|
Obesity, Morbid Diabetes Mellitus, Type 2 Gastric Bypass |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | 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 |
Serum, urine, stool
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Roux-En-Y Gastric Bypass |
| Gastric Banding |
| Sucessful Response to RYGB |
| Failed Response to RYGB |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Morbidly obese (BMI > 40 kg/m2) patients with T2D
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Synergy Bariatrics | Recruiting |
| Williamsville, New York, United States, 14221 | |
| Contact: Joseph Caruana, MD 716-565-3990 jcaruanamd@synergybariatrics.com | |
| Sisters of Charity Hospital | Recruiting |
| Buffalo, New York, United States, 14214 | |
| Contact: Joseph Caruana, MD 716-565-3990 jcaruanamd@synergybariatrics.com | |
| Principal Investigator: | Joseph A Caruana, M.D. | Synergy Bariatrics |
More Information
| Responsible Party: | Synergy Bariatrics, Sisters of Charity Hospital ( Joseph A. Caruana, M.D. ) |
| Study ID Numbers: | CPL200907A |
| Study First Received: | August 17, 2009 |
| Last Updated: | August 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00960765 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Type 2 Diabetes Mellitus Gastric Bypass Gastric Banding Endotoxin |
|
Body Weight Signs and Symptoms Obesity Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus |
Nutrition Disorders Endocrine System Diseases Overweight Overnutrition Obesity, Morbid Glucose Metabolism Disorders |
