Identify Bacteria Associated With Metabolic Diseases That Reside Both in Intestinal Crypts and in Blood (MICIMAB)

November 29, 2018 updated by: University Hospital, Toulouse

Identify Bacteria Associated With Metabolic Diseases That Reside Both in Intestinal Crypts and in Blood.

The investigators will compare 16sRDNA profile in cases and controls in order to identify bacteria associated with metabolic diseases that reside both in intestinal crypts and in blood.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Experimental evidence suggests that bacterial translocation from gut to tissue could be an initial step leading to diabetes. To test this hypothesis, a bacterial component that is highly conserved between different species of bacteria, the 16S rDNA gene will be analysed both in intestinal crypt and in blood in patients with type 2 diabetes, obese patients and control.

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

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

  • France
      • Toulouse, France, 31 052
        • University Hospital of Toulouse

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

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between 35 and 75 years old
  • Colonoscopy and biopsies required

Diabetes population:

  • Type 2 diabetes

Obese population:

  • Android obesity

Exclusion Criteria:

  • Inflammatory bowel disease
  • Colonic cancer
  • Bariatric surgery
  • Previous administration of antibiotic (within 15 days)
  • Pregnancy

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: obese patients
Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies
Other: obese patients
collection of blood sampling and biopsies
Experimental: Diabetic patients
Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies
Other: diabetic patients
collection of blood sampling and biopsies
Experimental: Patients free of obesity and diabetes
Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies
Other: patients free of obesity and diabetes
collection of blood sampling and biopsies
Experimental: patients free type 2 diabetes.
Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies
Other: patients free type 2 diabetes
collection of blood sampling and biopsies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rDNA comparison between cases and controls
Time Frame: 36 months
Comparison of 16sRDNA profile in cases and controls in order to identify bacteria associated with metabolic diseases that reside both in intestinal crypts and in blood.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Study Director: Jacques AMAR, MD PhD, CHU Toulouse
  • Principal Investigator: Jacques Moreau, MD, CHU Toulouse

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

February 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

July 22, 2014

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimate)

October 10, 2014

Study Record Updates

Last Update Posted (Actual)

December 3, 2018

Last Update Submitted That Met QC Criteria

November 29, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13 6936 03

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.

Subscribe