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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: diabetic patients; Other: obese patients; Other: patients free of obesity and diabetes; Other: patients free type 2 diabetes

• Registration Number: NCT02261831
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-07-22
• Study First Submitted QC: 2014-10-09
• Study First Posted: 2014-10-10
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-29
• Last Update Posted: 2018-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetic patients	diabetic patients	Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies
obese patients	obese patients	Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies
Patients free of obesity and diabetes	patients free of obesity and diabetes	Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies
patients free type 2 diabetes.	patients free type 2 diabetes	Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies

Primary Outcome Measures

Name	Time	Method
rDNA comparison between cases and controls	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.

Trial Locations

Locations (1)

University Hospital of Toulouse; 🇫🇷 Toulouse, France