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NCT02261831 Clinical Trial

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

Obesity Clinical Trial

— MICIMAB  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02261831
Other study ID # 13 6936 03
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2014
Est. completion date December 2017

Study information
Verified date November 2018
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 99
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• obese patients
collection of blood sampling and biopsies
• diabetic patients
collection of blood sampling and biopsies
• patients free of obesity and diabetes
collection of blood sampling and biopsies
• patients free type 2 diabetes
collection of blood sampling and biopsies

Locations
Country Name City State
France University Hospital of Toulouse Toulouse

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 36 months
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