Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458088
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-10
Brief Title:
Advanced Glycation Products and Vascular Complications in Type 1 Diabetes
Sponsor:
CHU de Reims
Organization:
CHU de Reims
Study Overview
Official Title:
Advanced Glycation Products and the Incidence of Vascular Complications in Type 1 Diabetes DIABAGE Study After More Than 5 Years
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIABAGE
Brief Summary:
DIABAGE Diabetes Advanced Glycation End products study was conducted between 2015 and 2017 It included 196 type 1 diabetic patients with more than 10 years of diabetes It revealed a significant association between the occurrence of vascular complications and tissular Advanced Glycation End products AGEs as well as with some circulating AGEs This protocol is a continuation of that initial research
Detailed Description:
The objective is to evaluate in patients included in the DIABAGE study the incident vascular events micro and macroangiopathic after at least 5 years of follow-up
The secondary objectives are
1 To assess the predictive value of the initial measurement of AGEs Advanced Glycation End Products on the occurrence of these complications
2 To study the correlation between tissue AGEs measured after 5 years of evolution and HbA1c values between the first inclusion and this new evaluation
Material and Methods
Experimental design monocentric observational study Reims University Hospital
Populationpatients patients included in the DIABAGE study are regularly followed in the Endocrinology Diabetology Nutrition department of the Reims University Hospital
Investigation plan
All patients in the DIABAGE study will be invited to participate The estimated participation rate is between 80 and 90
The explorations will be carried out as part of their usual follow-up during a short hospitalization day or week hospital depending on the patient A careful clinical examination will be conducted as well as a biological check-up If necessary investigations for chronic complications will be carried out including a fundus systolic pressure indexes an electrocardiogram and if necessary an evaluation of the Coronary Artery Calcium score Skin auto-fluorescence will also be measured using the AGE-Reader available at the University Hospital
Judgement criteria
Primary endpoint measurement of the incidence of micro and macro angiopathic vascular complications occurring during the follow-up of type 1 diabetic patients in the DIABAGE cohort
Secondary endpoints
Measurement of initial circulating and tissue AGEs
Measurement of tissue AGE delta defined as the difference between AGE after at least 5 years and baseline AGE
Repeat measurements of HbA1c over the follow-up period
The secondary objectives are
1 To assess the predictive value of the initial measurement of AGEs Advanced Glycation End Products on the occurrence of these complications
2 To study the correlation between tissue AGEs measured after 5 years of evolution and HbA1c values between the first inclusion and this new evaluation
Material and Methods
Experimental design monocentric observational study Reims University Hospital
Populationpatients patients included in the DIABAGE study are regularly followed in the Endocrinology Diabetology Nutrition department of the Reims University Hospital
Investigation plan
All patients in the DIABAGE study will be invited to participate The estimated participation rate is between 80 and 90
The explorations will be carried out as part of their usual follow-up during a short hospitalization day or week hospital depending on the patient A careful clinical examination will be conducted as well as a biological check-up If necessary investigations for chronic complications will be carried out including a fundus systolic pressure indexes an electrocardiogram and if necessary an evaluation of the Coronary Artery Calcium score Skin auto-fluorescence will also be measured using the AGE-Reader available at the University Hospital
Judgement criteria
Primary endpoint measurement of the incidence of micro and macro angiopathic vascular complications occurring during the follow-up of type 1 diabetic patients in the DIABAGE cohort
Secondary endpoints
Measurement of initial circulating and tissue AGEs
Measurement of tissue AGE delta defined as the difference between AGE after at least 5 years and baseline AGE
Repeat measurements of HbA1c over the follow-up period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None