Type1diabetesDIABAGENCT06458088
Advanced Glycation Products and Vascular Complications in Type 1 Diabetes
An observational study of Type1diabetes, run by CHU de Reims at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type1diabetes
- How many people
- 196 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Inclusion in initial DIABAGE study. * Follow-up at Reims hospital.
Who may be able to join
- Follow-up at Reims hospital.
Who cannot join
- Refusal to participate.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Reims
Reims, 51092
Damien JOLLY, Pr., 326788472 ext. 33, djolly@chu-reims.fr
About this study
Official title: Advanced Glycation Products and the Incidence of Vascular Complications in Type 1 Diabetes: DIABAGE Study After More Than 5 Years
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.
Read the 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:
- To assess the predictive value of the initial measurement of AGEs (Advanced Glycation End Products) on the occurrence of these complications.
- 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
- Type1diabetes
- Keywords
- Vascular complication, Diabetic retinopathy, Diabetic nephropathy, Diabetic neuropathy, Cardio-vascular events, Advanced Glycation End Products, AGE
- Medical subject headings
- Diabetic Retinopathy, Diabetic Nephropathies, Diabetic Neuropathies
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Tissular AGEs at initial inclusion and after follow-up
Measured: 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.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start25 Jan 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458088
- Sponsor's protocol ID
- PA23009
- Acronym
- DIABAGE
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35779209
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Glycation Products and the Incidence of Vascular Complications in Type 1 Diabetes: DIABAGE Study After More Than 5 Years
- ClinicalTrials.gov ID
- NCT06458088
- Acronym / sponsor ID
- DIABAGE / PA23009
- Conditions
- Type1diabetes
- Keywords
- Vascular complication, Diabetic retinopathy, Diabetic nephropathy, Diabetic neuropathy, Cardio-vascular events, Advanced Glycation End Products, AGE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the predictive value of the initial measurement of AGEs (Advanced Glycation End Products) on the occurrence of these complications.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Inclusion in initial DIABAGE study. * Follow-up at Reims hospital.
Key inclusion criteria (1 listed)
- Follow-up at Reims hospital.
Key exclusion criteria (1 listed)
- Refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between baseline AGE values and incident cases of vascular complications.
Time frame: At inclusion
* Occurrence of a cardiovascular event. * Appearance or aggravation of ophthalmological involvement. * Appearance or worsening of diabetic nephropathy. * Appearance of diabetic neuropathy.
2 secondary outcomes
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.
Time frame: At inclusion
The association between baseline AGE values and the occurrence of macrovascular damage.
Time frame: At inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Background: PubMed 35779209Diallo 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.
Related trials for Type1diabetes
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
Active, not recruitingPhase 2
Probiotics in Newly Diagnosed T1D
Type 1 Diabetes, Type1diabetes
RecruitingObservational study
Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children
Type1diabetes
Active, not recruitingPhase 2
Reducing Innate Inflammation in New Onset Type 1 Diabetes
Type 1 Diabetes, type1diabetes
Recruiting
Cardiometabolic Effects of Non-Nutritive Sweeteners (NNS) in Type 1 Diabetes (T1D)
Non-Nutritive Sweetener, Type 1 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type1diabetes, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara BARRAUD, Dr. (03.10.73.63.82, sbarraud@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between baseline AGE values and incident cases of vascular complications. (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06458088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.