NCT00960765

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2009

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2009

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

5.7 years

First QC Date

August 17, 2009

Last Update Submit

January 27, 2016

Conditions

Obesity, MorbidDiabetes Mellitus, Type 2Gastric Bypass

Keywords

Type 2 Diabetes MellitusGastric BypassGastric BandingEndotoxin

Study Arms (4)

Roux-En-Y Gastric Bypass

Gastric Banding

Sucessful Response to RYGB

Failed Response to RYGB

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sisters of Charity Hospital

Buffalo, New York, 14214, United States

Location

Synergy Bariatrics

Williamsville, New York, 14221, United States

Location

Related Publications (2)

  • 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.

    PMID: 23804543DERIVED

  • 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.

    PMID: 22508715DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, urine, stool

MeSH Terms

Conditions

Obesity, MorbidDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Joseph A Caruana, M.D.

    Synergy Bariatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Director

Study Record Dates

First Submitted

August 17, 2009

First Posted

August 18, 2009

Study Start

August 1, 2009

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

US(2)