Screening and Understanding of the Pre-diabetes: DECODIAB

NCT ID: NCT01739868

Last Updated: 2015-04-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2018-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

Biopsies of muscular and fat tissue

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)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Subject exclusion period in a previous study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bertrand CARIOU, Pr

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

Nantes University Hospital

Nantes, , France

Countries

France

Other Identifiers

09/9-A

Identifier Type: -

Identifier Source: org_study_id