Clinical trial NCT06458088: Advanced Glycation Products and Vascular Complications in Type 1 Diabetes
Official title: Advanced Glycation Products and the Incidence of Vascular Complications in Type 1 Diabetes: DIABAGE Study After More Than 5 Years
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type1diabetes
Keywords: Vascular complication
Diabetic retinopathy
Diabetic nephropathy
Diabetic neuropathy
Cardio-vascular events
Advanced Glycation End Products
AGE
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Inclusion in initial DIABAGE study.
* Follow-up at Reims hospital.

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).

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.

Eligibility criteria: Inclusion Criteria:

* Inclusion in initial DIABAGE study.
* Follow-up at Reims hospital.

Exclusion Criteria:

- Refusal to participate.

Primary outcomes:
measure: Association between baseline AGE values and incident cases of vascular complications.
timeFrame: At inclusion
Secondary outcomes:
measure: The correlation between the tissue AGE deltas (defined by the difference between the AGEs at 5 years and the initial AGEs) and the cumulative HbA1c over the 5 years.
timeFrame: At inclusion
measure: The association between baseline AGE values and the occurrence of macrovascular damage.
timeFrame: At inclusion
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References:
citation: Diallo AM, Jaisson S, Barriquand R, Lukas C, Barraud S, Decoudier B, Francois M, Ly S, Mahmoudi R, Arndt C, Nazeyrollas P, Gillery P, Delemer B. Association Between the Tissue and Circulating Advanced Glycation End-Products and the Micro- and Macrovascular Complications in Type 1 Diabetes: The DIABAGE Study. Diabetes Ther. 2022 Aug;13(8):1531-1546. doi: 10.1007/s13300-022-01285-1. Epub 2022 Jul 2.