Advanced Glycation Products and Vascular Complications in Type 1 Diabetes (DIABAGE)

CHU de Reims

Status

Enrolling

Conditions

Type1diabetes

Study type

Observational

Funder types

Other

Identifiers

NCT06458088

PA23009

Details and patient eligibility

About

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.

Full 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:

To assess the predictive value of the initial measurement of AGEs (Advanced Glycation End Products) on the occurrence of these complications.
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.

Enrollment

196 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria