Advanced Glycation Products and Vascular Complications in Type 1 Diabetes
- Conditions
- Type1diabetes
- Registration Number
- NCT06458088
- Lead Sponsor
- CHU de Reims
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 196
- Inclusion in initial DIABAGE study.
- Follow-up at Reims hospital.
- Refusal to participate.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Association between baseline AGE values and incident cases of vascular complications. At inclusion * Occurrence of a cardiovascular event.
* Appearance or aggravation of ophthalmological involvement.
* Appearance or worsening of diabetic nephropathy.
* Appearance of diabetic neuropathy.
- Secondary Outcome Measures
Name Time Method 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. At inclusion Tissular AGEs at initial inclusion and after follow-up
The association between baseline AGE values and the occurrence of macrovascular damage. At inclusion * Cardiovascular event as defined in the primary endpoint.
* Or medically treated arterial injury (coronary stenosis objectified on medically treated coronary angiography, SPI \< 0.9 without revascularization, stenosis or occlusion objectified on lower extremity arterial Doppler and carotid stenosis \> 60% without endarterectomy).
* Tissular and plasmatic AGEs.
Trial Locations
- Locations (1)
Chu Reims
🇫🇷Reims, France