NCT02811575

Brief Summary

Type 2 diabetes is the predominant type of diabetes. Because a quiet evolution, it is difficult to have a rapid diagnose. A better knowledge about pathophysiological mechanisms at the origin of type 2 diabetes and about its complications could make it possible to improve the prevention and the treatment of this disease. Research team developped a new research axis : the microbiota of the intestinal mucosa. They proved a translocation process of intestinal bacteria from the intestinal mucosa to different tissue of the organism implicated in glucose homeostasis. This mechanism is involved in the type 2 diabetes development. A clinical study (MICIMAB) of predictive biomarkers of diabetes and obesity is ongoing. In parallel, the same team explored the role of intestinal immunity modifications in the bacteria translocation from the gut to the blood circulation. They already have some results on animal model but not yet in human. In animal model, a solid reduction of lymphocytes T CD4 Th17 in the intestinal wall is responsable of the translocation of intestinal bacteria and in the induction of a metabolic inflammation wich promotes insulin resistance, abdominal obesity development and type 2 diabetes. The aim of this study is to explore this hypothesis in human to have therapeutic solution later.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2021

Completed
Last Updated

February 7, 2022

Status Verified

February 1, 2022

Enrollment Period

4.3 years

First QC Date

June 21, 2016

Last Update Submit

February 4, 2022

Conditions

Type 2 Diabetes

Keywords

Coloscopy

Outcome Measures

Primary Outcomes (1)

  • Number of lymphocyte TCD4 Th17 in colon sample

    After colon biopsy, lymphocytes TCD4 Th17 are counted in biopsy sample.

    Day 1

Secondary Outcomes (12)

  • Number of lymphocyte TCD4 Th17 in ileon sample

    Day 1

  • Number of CD45+ cells in colon sample

    Day 1

  • Number of CD45+ cells in ileon sample

    Day 1

  • Activation of CD45+ cells in colon sample

    Day 1

  • Activation of CD45+ cells in ileon sample

    Day 1

  • +7 more secondary outcomes

Study Arms (2)

Patients with diabetes

Patients with type 2 diabetes will have biopsy during coloscopy.

Other: Biopsy

Control

Patients without type 2 diabetes will have biopsy during coloscopy.

Other: Biopsy

Interventions

BiopsyOTHER

Ileon and colon biopsy

ControlPatients with diabetes

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with a diagnoses of type 2 diabetes and patient who do not have a know diabetes diagnose.

You may qualify if:

  • Coloscopy indication
  • Capacity to give a written informed consent

You may not qualify if:

  • Type 1 diabetes
  • Severe renal failure
  • Antecedent of liver fibrosis and/or liver failure
  • Antecedent of inflammatory bowel disease, lymphocyte colitis, celiac disease or colon cancer
  • Antecedent of obesity surgery or of total colectomy
  • Antecedent of documented intestinal ischaemia
  • Congenital of acquired immune deficiency
  • Chronic viral infection
  • Antibiotic of probiotic the month before the coloscopy
  • Pregnancy
  • Patients under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Toulouse

Toulouse, 31059, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Ileon and colon biopsy

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Pierre Gourdy

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2016

First Posted

June 23, 2016

Study Start

December 1, 2016

Primary Completion

March 4, 2021

Study Completion

March 4, 2021

Last Updated

February 7, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)