Status:

COMPLETED

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

Lead Sponsor:

CPL Associates

Collaborating Sponsors:

Synergy Bariatrics

Sisters of Charity Hospital

Conditions:

Obesity, Morbid

Diabetes Mellitus, Type 2

Eligibility:

All Genders

18-95 years

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-...

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 ...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

August 1 2009

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 1 2015

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT00960765

Start Date

August 1 2009

End Date

April 1 2015

Last Update

January 28 2016

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Sisters of Charity Hospital

Buffalo, New York, United States, 14214

2

Synergy Bariatrics

Williamsville, New York, United States, 14221