NCT06458088

Advanced Glycation Products and Vascular Complications in Type 1 Diabetes

Advanced Glycation Products and the Incidence of Vascular Complications in Type 1 Diabetes: DIABAGE Study After More Than 5 Years

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 196 (estimated)
• Sponsor: CHU de Reims · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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). Population/patients: 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.

Conditions

• Type1diabetes

Timeline

• Start date: 2023-01-25
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2024-06-13
• Last updated: 2024-06-13

Locations

1 site across 1 country: France