Screening and Understanding of the Pre-diabetes: DECODIAB

NCT01739868 | Unknown

• 1 other identifier: 09/9-A
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study is to understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in the population of patients with pre-diabetes.

Conditions

Pre-diabetes

Keywords

Pre-diabetes; Type 2 diabetes; Biomarkers; Diabetes risk score

Outcome Measures

Primary Outcomes (1)

• To identify new biomarkers

  The main objective of the study is to understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in the population of patients with pre-diabetes

  5 years

Secondary Outcomes (4)

• To identify new therapeutic targets

  5 years

• To connect identified biomarkers with the degree of insulinoresistance

  5 years

• Number of patients with high Diabetes Risk Score and pre-diabetes

  5 years

• Number of patients with others cardiovascular risk factors

  5 years

Interventions

Biopsies of muscular and fat tissue OTHER

3 half days of metabolic exploration including blood sample, urinary taking, OGTT (oral glucose tolerance test), biopsies of muscular and fat tissue: * 1 visit the first year (inclusion visit) * 1 visit at the end of 5 years of follow-up or in the appearance of type 2 diabetes * 1 intermediary visit (in 3 years) or activated by the following conditions: * Escalation of the glycemia (increase of 0.1g / l of the glycemia and/or 0.3 % of the HbA1c) * Normalization of the glycemia (fasting blood glucose \< 1 g/l)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years)
• Subjects with diabetes risk score ≥ 12 or with impaired fasting glucose: blood glucose ≥ 1.10 g/l and \< 1 .26 g/L
• And with impaired fasting glucose : blood glucose ≥ 1.10 g/l and \< 1 .26 g/L ; or blood glucose ≥ 1g/l and \< 1,1 g/L WITH HbA1C ≥ 6,5%
• Signed informed consent
• Subjects affiliated with an appropriate social security system

You may not qualify if:

• Fasting glycemia ≥ 1.26 g/l
• Fasting glycemia ≤ 1.10 g/l AND HbA1C \< 6,5%
• Fasting glycemia \< 1 g/l
• Subjects previously treated with oral anti-diabetic: metformin, glitazones, inhibitors of α-glucosidase, sulfonylurea, repaglinide, inhibitors of DPP-IV.
• Subjects previously treated with insulin, except gestational diabetes
• Severe coagulation disorders
• Thrombocytopenia \< 100 000/mm 3
• Severe psychiatric disorders
• Severe renal insufficiency (creatinine clearance \< 30 ml/min)
• Severe hepatic insufficiency
• Alcohol abuse (\> 30g/j)
• Contra-indication in the realization of the local anesthetic
• Subject unable to follow the study during the 5 years of follow-up

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, France

Location

MeSH Terms

Conditions

Glucose Intolerance; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Bertrand CARIOU, Pr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2012
• First Posted: December 4, 2012
• Study Start: April 1, 2011
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 16, 2015

Record last verified: 2015-04

Locations

FR (1)