Identify Bacteria Associated With Metabolic Diseases That Reside Both in Intestinal Crypts and in Blood
MICIMAB
1 other identifier
interventional
99
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Feb 2014
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 22, 2014
CompletedFirst Posted
Study publicly available on registry
October 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedDecember 3, 2018
November 1, 2018
3.8 years
July 22, 2014
November 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
obese patients
EXPERIMENTALTotal blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies
Diabetic patients
EXPERIMENTALTotal blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies
Patients free of obesity and diabetes
EXPERIMENTALTotal blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies
patients free type 2 diabetes.
EXPERIMENTALTotal blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies
Interventions
collection of blood sampling and biopsies
collection of blood sampling and biopsies
Eligibility Criteria
You may qualify if:
- Between 35 and 75 years old
- Colonoscopy and biopsies required
- Diabetes population:
- Type 2 diabetes
- Obese population:
- Android obesity
You may not qualify if:
- Inflammatory bowel disease
- Colonic cancer
- Bariatric surgery
- Previous administration of antibiotic (within 15 days)
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Toulouse
Toulouse, 31 052, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jacques AMAR, MD PhD
University Hospital, Toulouse
- PRINCIPAL INVESTIGATOR
Jacques Moreau, MD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2014
First Posted
October 10, 2014
Study Start
February 1, 2014
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
December 3, 2018
Record last verified: 2018-11