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

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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Key information

Conditions

Obesity, Morbid Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Gastric Bypass Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sisters of Charity Hospital, Buffalo, New York, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

CPL Associates

Other

Collaborators

Sisters of Charity Hospital
Synergy Bariatrics
The New York State Center of Excellence in Bioinformatics & Life Sciences

Registry information

Official study 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

Important dates

Study start: 2009
Primary completion: 2015
Study completion: 2015
First posted: Aug 18, 2009
Registry last updated: Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed