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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2015-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Obesity, Morbid Diabetes Mellitus, Type 2 Gastric Bypass

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Roux-En-Y Gastric Bypass

No interventions assigned to this group

Gastric Banding

No interventions assigned to this group

Sucessful Response to RYGB

No interventions assigned to this group

Failed Response to RYGB

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No