Clinical trial NCT00960765: Endotoxin and Intestinal Flora Before and After Gastric Bypass or Banding in Diabetics
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Diabetes Mellitus, Type 2
Gastric Bypass
Keywords: Type 2 Diabetes Mellitus
Gastric Bypass
Gastric Banding
Endotoxin
Lead sponsor: CPL Associates
Sponsor class: OTHER
Collaborators: name: Synergy Bariatrics
name: Sisters of Charity Hospital
name: The New York State Center of Excellence in Bioinformatics & Life Sciences
First posted: 2009-08-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Morbidly obese (BMI \> 40 kg/m2) patients with T2D

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Sisters of Charity Hospital
state: New York
city: Williamsville
country: United States
facility: Synergy Bariatrics
state: New York
Study officials:
affiliation: Synergy Bariatrics
name: Joseph A Caruana, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dandona P, Ghanim H, Monte SV, Caruana JA, Green K, Abuaysheh S, Lohano T, Schentag J, Dhindsa S, Chaudhuri A. Increase in the mediators of asthma in obesity and obesity with type 2 diabetes: reduction with weight loss. Obesity (Silver Spring). 2014 Feb;22(2):356-62. doi: 10.1002/oby.20524. Epub 2013 Sep 4.
citation: Ghanim H, Monte SV, Sia CL, Abuaysheh S, Green K, Caruana JA, Dandona P. Reduction in inflammation and the expression of amyloid precursor protein and other proteins related to Alzheimer's disease following gastric bypass surgery. J Clin Endocrinol Metab. 2012 Jul;97(7):E1197-201. doi: 10.1210/jc.2011-3284. Epub 2012 Apr 16.