Therapeutic Innovation in Type 2 DIABetes (IT-DIAB)

Pre-diabetes Clinical Trial

— IT-DIAB  

Official title:

IT-DIAB (Therapeutic Innovation in Type 2 Diabetes) : Prospective Follow-up of a Cohort of Patients With Pre-diabetes Over 10 Years

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01218061
• Other study ID #: PROG/09/11
• Status: Active, not recruiting
• Phase: N/A
• First received: October 7, 2010
• Last updated: June 14, 2017
• Start date: June 2010
• Est. completion date: June 2023

Study information

• Verified date: June 2017
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of the study is to follow prospectively a cohort of patients with pre-diabetes 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 this population.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 366
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (=18 years)

• Subjects with diabetes risk score = 15

• Subjects with impaired fasting glucose: blood glucose = 1.10 g/l and < 1 .26 g/L

• Subjects affiliated with an appropriate social security system

Exclusion Criteria:

• Fasting glycemia = 1.26 g/l

• Fasting glycemia = 1.10 g/l

• Subjects previously treated with oral anti-diabetic: metformin, glitazones, inhibitors of a-glucosidase, sulfonylurea, repaglinide, inhibitors of DPP-IV, GLP-1 R agonists.

• 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 (TP < 50%)

• Alcohol abuse (> 30g/j)

• Patient's opposition

• Subject unable to follow the study during the 5 years of follow-up

• Subject exclusion period in a previous study

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Pre-diabetes
• Prediabetic State

Intervention

Other:
• Pre-diabetes screening
The timing of the study is :- Screening of high metabolic risk patients based on a clinical score : Finnish Diabetes Risk Score = 15- if Diabetes Risk Score = 15 or if history of blood glucose between 1.10 and 1.26 g/l (impaired fasting glucose): measuring fasting glycaemia + HbA1C + lipids profile + creatinemia + liver enzymes- if fasting blood glucose between 1.10 and 1.26 g/l (=V0):* OGTT (oral glucose tolerance test) to identify subjects with impaired glucose tolerance (optional)* establishment of a serum bank to identify biomarkers (serum, genomic, proteomic) - to plan for 10 years annual follow-up (V1 to V10) with blood sample (fasting glycemia + HbA1C + lipids profile + creatinemia + liver enzymes + serum bank (not after V5)) Making a total of 11 visits (V0-V10) with 6 blood samples.

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	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 this population	The main objective of the study is to follow prospectively a cohort of patients with pre-diabetes 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 this population	10 years
Secondary	Number of patients with pre-diabetes	To evaluate the prevalence of pre-diabetes in the region of Nantes	10 years
Secondary	HbA1c measurement	To evaluate the role of HbA1C in screening for pre-diabetes and T2D	10 years
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	10 years
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	10 years
Secondary	Relation between "working hours and conditions" and metabolic disease	To evaluate the impact of working hours and conditions on the prevalence of metabolic diseases (pre-diabetes, dyslipidemia…)	10 years