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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00960765
• Other study ID #: CPL200907A
• Status: Completed
• Phase: N/A
• First received: August 17, 2009
• Last updated: January 27, 2016
• Start date: August 2009
• Est. completion date: April 2015

Study information

• Verified date: January 2016
• Source: CPL Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Gastric Bypass
• Obesity, Morbid

Locations

Country	Name	City	State
United States	Sisters of Charity Hospital	Buffalo	New York
United States	Synergy Bariatrics	Williamsville	New York

Sponsors (4)

Lead Sponsor	Collaborator
CPL Associates	Sisters of Charity Hospital, Synergy Bariatrics, The New York State Center of Excellence in Bioinformatics & Life Sciences

Country where clinical trial is conducted

United States,