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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by CPL Associates
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT00960765
First received: August 17, 2009
Last updated: August 1, 2012
Last verified: June 2011
  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: 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

Resource links provided by NLM:


Further study details as provided by CPL Associates:

Biospecimen Retention:   Samples Without DNA

Serum, urine, stool


Estimated Enrollment: 60
Study Start Date: August 2009
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2011 (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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Morbidly obese (BMI > 40 kg/m2) patients with T2D

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00960765

Locations
United States, New York
Sisters of Charity Hospital Recruiting
Buffalo, New York, United States, 14214
Contact: Joseph Caruana, MD    716-565-3990    jcaruanamd@synergybariatrics.com   
Synergy Bariatrics Recruiting
Williamsville, New York, United States, 14221
Contact: Joseph Caruana, MD    716-565-3990    jcaruanamd@synergybariatrics.com   
Sponsors and Collaborators
CPL Associates
Synergy Bariatrics
Sisters of Charity Hospital
The New York State Center of Excellence in Bioinformatics & Life Sciences
Investigators
Principal Investigator: Joseph A Caruana, M.D. Synergy Bariatrics
  More Information

No publications provided by CPL Associates

Additional 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
Study First Received: August 17, 2009
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by CPL Associates:
Type 2 Diabetes Mellitus
Gastric Bypass
Gastric Banding
Endotoxin

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

ClinicalTrials.gov processed this record on October 20, 2014