Screening and Understanding of the Pre-diabetes: DECODIAB

Pre-diabetes Clinical Trial

— DECODIAB  

Official title:

Screening and Understanding of the Pre-diabetes: DECODIAB

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01739868
• Other study ID #: 09/9-A
• Status: Active, not recruiting
• Phase: N/A
• First received: November 23, 2012
• Last updated: April 15, 2015
• Start date: April 2011
• Est. completion date: April 2018

Study information

• Verified date: April 2015
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 103
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 a-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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance
• Pre-diabetes
• Prediabetic State

Intervention

Other:
• 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)

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To identify new therapeutic targets	To identify new therapeutic targets for the prevention of the appearance of the diabetes in the population of patients with pre-diabetes	5 years	No
Secondary	To connect identified biomarkers with the degree of insulinoresistance	To connect identified biomarkers with the degree of insulinoresistance (HOMA-R) and with ß pancreatic function (IOG) in the population of patients with pre-diabetes.	5 years	No
Secondary	Number of patients with high Diabetes Risk Score and pre-diabetes	To evaluate the interest of the Diabetes Risk Score in identifying subjects with pre-diabetes in the French population	5 years	No
Secondary	Number of patients with others cardiovascular risk factors	To evaluate the prevalence of others cardiovascular risk factors associated with pre-diabetes: dyslipidemia, hypertension, metabolic liver disease	5 years	No