An observational study in Type1diabetes, sponsored by CHU de Reims. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-13.
Sponsored by CHU de Reims · Observational
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.
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:
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:
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:
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 196 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →CHU de Reims is the lead sponsor of 267 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Association between baseline AGE values and incident cases of vascular complications.
* Occurrence of a cardiovascular event. * Appearance or aggravation of ophthalmological involvement. * Appearance or worsening of diabetic nephropathy. * Appearance of diabetic neuropathy.
Time frame: At inclusion
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.
Tissular AGEs at initial inclusion and after follow-up
Time frame: At inclusion
The association between baseline AGE values and the occurrence of macrovascular damage.
* 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.
Time frame: At inclusion
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CHU de Reims