This trial is active, not recruiting.

Condition pre-diabetes
Treatment biopsies of muscular and fat tissue
Sponsor Nantes University Hospital
Start date April 2011
End date April 2018
Trial size 103 participants
Trial identifier NCT01739868, 09/9-A


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label

Primary Outcomes

To identify new biomarkers
time frame: 5 years

Secondary Outcomes

To identify new therapeutic targets
time frame: 5 years
To connect identified biomarkers with the degree of insulinoresistance
time frame: 5 years
Number of patients with high Diabetes Risk Score and pre-diabetes
time frame: 5 years
Number of patients with others cardiovascular risk factors
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Screening and Understanding of the Pre-diabetes: DECODIAB
Principal investigator Bertrand CARIOU, Pr
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Nantes University Hospital.