Endotoxin and Intestinal Flora Before and After Gastric Bypass or Banding in Diabetics
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00960765
Recruitment Status :
First Posted : August 18, 2009
Last Update Posted : January 28, 2016
Sisters of Charity Hospital
The New York State Center of Excellence in Bioinformatics & Life Sciences
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, MorbidDiabetes Mellitus, Type 2Gastric Bypass
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.
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, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 95 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Morbidly obese (BMI > 40 kg/m2) patients with T2D
Age > 18 years of age
Morbid obesity (BMI > 40 kg/m2)
Confirmed T2D diagnosis/date of onset
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