Endotoxin and Intestinal Flora Before and After Gastric B... | NCT00960765

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

NCT00960765

Sponsor

CPL Associates

Status

Completed

Last Update Posted

Jan 28, 2016Estimated

Enrollment

15Actual

Phase

Not provided

Conditions

Obesity, Morbid
Diabetes Mellitus, Type 2
Gastric Bypass

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Aug 17, 2009

First Submission Date that Met QC Criteria

Aug 17, 2009

First Posted Date

Aug 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2016

Last Update Posted Date

Jan 28, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Scott Monte, Program Director, CPL AssociatesPrincipal Investigator

Lead Sponsor

CPL AssociatesOTHER

Collaborators

Name	Class
Synergy Bariatrics	UNKNOWN
Sisters of Charity Hospital	UNKNOWN
The New York State Center of Excellence in Bioinformatics & Life Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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-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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

15Actual

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Morbidly obese (BMI > 40 kg/m2) patients with T2D

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph A Caruana, M.D.	Synergy Bariatrics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sisters of Charity Hospital		Buffalo	New York	14214	United States
Synergy Bariatrics

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23804543	Derived	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.
22508715	Derived

Label	Type	Description	Intervention Names
Roux-En-Y Gastric Bypass
Gastric Banding
Sucessful Response to RYGB
Failed Response to RYGB

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

ID	Term
D009767	Obesity, Morbid
D003924	Diabetes Mellitus, Type 2