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Completed

NCT Number: NCT02261831

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

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.

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Toulouse

Toulouse, 31 052, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

obese patients

Other

collection of blood sampling and biopsies

Diabetic Patients

Other

collection of blood sampling and biopsies

patients free of obesity and diabetes

Other

collection of blood sampling and biopsies

patients free type 2 diabetes

Other

collection of blood sampling and biopsies

Primary outcomes

  1. rDNA comparison between cases and controls

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: MICIMAB

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 10, 2014
Registry last updated
Dec 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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