Type1diabetes
Conditions
Keywords
Vascular complication, Diabetic retinopathy, Diabetic nephropathy, Diabetic neuropathy, Cardio-vascular events, Advanced Glycation End Products, AGE
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.
Interventions
None listed
Sponsors
CHU de Reims
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inclusion in initial DIABAGE study. * Follow-up at Reims hospital.
Exclusion criteria
\- Refusal to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Contacts
Primary ContactSara BARRAUD, Dr.
Outcome results
None listed