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Endotoxin and Intestinal Flora Before and After Gastric Bypass or Banding in Diabetics

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ClinicalTrials.gov Identifier: NCT00960765
Recruitment Status : Completed
First Posted : August 18, 2009
Last Update Posted : January 28, 2016
Synergy Bariatrics
Sisters of Charity Hospital
The New York State Center of Excellence in Bioinformatics & Life Sciences
Information provided by (Responsible Party):
Scott Monte, CPL Associates

Brief Summary:
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 or disease
Obesity, Morbid Diabetes Mellitus, Type 2 Gastric Bypass

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: 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
Study Start Date : August 2009
Primary Completion Date : April 2015
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Roux-En-Y Gastric Bypass
Gastric Banding
Sucessful Response to RYGB
Failed Response to RYGB

Biospecimen Retention:   Samples Without DNA
Serum, urine, stool

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Morbidly obese (BMI > 40 kg/m2) patients with T2D

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00960765

United States, New York
Sisters of Charity Hospital
Buffalo, New York, United States, 14214
Synergy Bariatrics
Williamsville, New York, United States, 14221
Sponsors and Collaborators
CPL Associates
Synergy Bariatrics
Sisters of Charity Hospital
The New York State Center of Excellence in Bioinformatics & Life Sciences
Principal Investigator: Joseph A Caruana, M.D. Synergy Bariatrics

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Scott Monte, Program Director, CPL Associates
ClinicalTrials.gov Identifier: NCT00960765     History of Changes
Other Study ID Numbers: CPL200907A
First Posted: August 18, 2009    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by Scott Monte, CPL Associates:
Type 2 Diabetes Mellitus
Gastric Bypass
Gastric Banding

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity, Morbid
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms