- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00960765
Endotoxin and Intestinal Flora Before and After Gastric Bypass or Banding in Diabetics
January 27, 2016 updated by: Scott Monte, CPL Associates
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
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.
Study Overview
Status
Completed
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.
Study Type
Observational
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Buffalo, New York, United States, 14214
- Sisters of Charity Hospital
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Williamsville, New York, United States, 14221
- Synergy Bariatrics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Morbidly obese (BMI > 40 kg/m2) patients with T2D
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Roux-En-Y Gastric Bypass
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Gastric Banding
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Sucessful Response to RYGB
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Failed Response to RYGB
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Joseph A Caruana, M.D., Synergy Bariatrics
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
August 17, 2009
First Submitted That Met QC Criteria
August 17, 2009
First Posted (Estimate)
August 18, 2009
Study Record Updates
Last Update Posted (Estimate)
January 28, 2016
Last Update Submitted That Met QC Criteria
January 27, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPL200907A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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