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

Completed

Conditions studied: Obesity, Morbid, Diabetes Mellitus, Type 2, Gastric Bypass

In brief

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.

Key facts

Study ID

NCT00960765

Run by

CPL Associates

People needed

15

Starts

2009-08-01

Expected to finish

2015-04-01

Last updated by the study team

2016-01-28

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years of age
• Morbid obesity (BMI > 40 kg/m2)
• Confirmed T2D diagnosis/date of onset

You may not qualify if…

• 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

Where it is running

• Sisters of Charity Hospital — Buffalo, New York, United States
• Synergy Bariatrics — Williamsville, New York, United States

Full record on ClinicalTrials.gov

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