NCT06458088

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
196

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

1.9 years

First QC Date

June 10, 2024

Last Update Submit

June 10, 2024

Conditions

Keywords

Vascular complicationDiabetic retinopathyDiabetic nephropathyDiabetic neuropathyCardio-vascular eventsAdvanced Glycation End ProductsAGE

Outcome Measures

Primary Outcomes (1)

  • 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.

    At inclusion

Secondary Outcomes (2)

  • 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

  • The association between baseline AGE values and the occurrence of macrovascular damage.

    At inclusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Follow-up at Reims hospital.

You may not qualify if:

  • \- Refusal to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

Reims, 51092, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35779209BACKGROUND

MeSH Terms

Conditions

Diabetic RetinopathyDiabetic NephropathiesDiabetic Neuropathies

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Sara BARRAUD, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2024

First Posted

June 13, 2024

Study Start

January 25, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Locations