Advanced Glycation Products and Vascular Complications in Type 1 Diabetes
NCT ID: NCT06458088
Last Updated: 2024-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
196 participants
OBSERVATIONAL
2023-01-25
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Follow-up at Reims hospital.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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CHU de Reims
OTHER
Responsible Party
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Locations
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Chu Reims
Reims, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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PA23009
Identifier Type: -
Identifier Source: org_study_id
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