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

NCT ID: NCT02261831

Last Updated: 2018-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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obese patients

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

Group Type EXPERIMENTAL

obese patients

Intervention Type OTHER

collection of blood sampling and biopsies

Diabetic patients

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

Group Type EXPERIMENTAL

diabetic patients

Intervention Type OTHER

collection of blood sampling and biopsies

Patients free of obesity and diabetes

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

Group Type EXPERIMENTAL

patients free of obesity and diabetes

Intervention Type OTHER

collection of blood sampling and biopsies

patients free type 2 diabetes.

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

Group Type EXPERIMENTAL

patients free type 2 diabetes

Intervention Type OTHER

collection of blood sampling and biopsies

Interventions

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obese patients

collection of blood sampling and biopsies

Intervention Type OTHER

diabetic patients

collection of blood sampling and biopsies

Intervention Type OTHER

patients free of obesity and diabetes

collection of blood sampling and biopsies

Intervention Type OTHER

patients free type 2 diabetes

collection of blood sampling and biopsies

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacques AMAR, MD PhD

Role: STUDY_DIRECTOR

University Hospital, Toulouse

Jacques Moreau, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital of Toulouse

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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13 6936 03

Identifier Type: -

Identifier Source: org_study_id

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