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

Primary Purpose

Obesity

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

obese patients

diabetic patients

patients free of obesity and diabetes

patients free type 2 diabetes

About this trial

This is an interventional diagnostic trial for Obesity focused on measuring bacterial, gut, type 2 diabetes., 16S rDNA gene, intestinal crypt

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University Hospital of Toulouse

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

obese patients

Diabetic patients

Patients free of obesity and diabetes

patients free type 2 diabetes.

Arm Description

Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies

Outcomes

Primary Outcome Measures

rDNA comparison between cases and controls

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02261831

First Posted

July 22, 2014

Last Updated

November 29, 2018

Sponsor

University Hospital, Toulouse

1. Study Identification

Unique Protocol Identification Number

NCT02261831

Brief Title

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

Acronym

MICIMAB

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Toulouse

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

bacterial, gut, type 2 diabetes., 16S rDNA gene, intestinal crypt

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

obese patients

Arm Type

Experimental

Arm Description

Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies

Arm Title

Diabetic patients

Arm Type

Experimental

Arm Description

Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies

Arm Title

Patients free of obesity and diabetes

Arm Type

Experimental

Arm Description

Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies

Arm Title

patients free type 2 diabetes.

Arm Type

Experimental

Arm Description

Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies

Intervention Type

Other

Intervention Name(s)

obese patients

Intervention Description

collection of blood sampling and biopsies

Intervention Type

Other

Intervention Name(s)

diabetic patients

Intervention Description

collection of blood sampling and biopsies

Intervention Type

Other

Intervention Name(s)

patients free of obesity and diabetes

Intervention Description

collection of blood sampling and biopsies

Intervention Type

Other

Intervention Name(s)

patients free type 2 diabetes

Intervention Description

collection of blood sampling and biopsies

Primary Outcome Measure Information:

Title

rDNA comparison between cases and controls

Description

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.

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacques AMAR, MD PhD

Organizational Affiliation

CHU Toulouse

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jacques Moreau, MD

Organizational Affiliation

CHU Toulouse

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Toulouse

City

Toulouse

ZIP/Postal Code

31 052

Country

France

12. IPD Sharing Statement

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

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