Targeting Glutamine Metabolism to Prevent Diabetic Cardiovascular Complications (GLUTADIAB)

  • STATUS
    Recruiting
  • End date
    Jan 16, 2024
  • participants needed
    975
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 24 July 2022

Summary

Experimental data suggest that glutamine catabolism in involved in the activation of macrophages by generating TCA(Tricarboxylic acid) intermediates that promote the pro-inflammatory polarization of macrophages. The project investigates the possible link between glutaminolysis, monocytes polarization and diabetes related cardiovascular complications in humans

Description

The aim of the study is to investigate the role of glutamine metabolism in the pro-inflammatory activation of macrophages in diabetes and related cardiovascular complications.

The study focuses on 3 adult patients' population with different diabetic status and level of cardiovascular risk:

  • Patients with uncomplicated type 1 or type 2 diabetes and low cardiovascular risk
  • Patients with uncomplicated type 1 or type 2 diabetes and high cardiovascular risk
  • Patients with complicated type 1 or type 2 diabetes

Participants (n=975) will be recruited at clinical sites, in the diabetes and cardiology departments (APHP, Bichat - Claude-Bernard Hospital and APHP, Lariboisière Hospital), over a 2-year period.

The study will consist in a single visit. During a scheduled hospitalization or consultation as part of the follow-up of their diabetes or as part of the follow-up of their cardiological problems, clinical data will be collected as well as additional blood and urine samples for analyses and biobanking. There will be no other intervention specific to the study.

Details
Condition Glutamine, Diabetic, Cardiovascular Complications
Treatment Bio collection
Clinical Study IdentifierNCT04353869
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on24 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

or more years of diabetes
% < HbA1c < 10%
no history of cardiovascular event, diabetic microvascular complications (kidney
Coronary artery calcium score < 100 (assessment < 12 months)
function normal and albuminuria/creatininuria < 30 mg/g)
or more years of diabetes
Group 2: Patients with uncomplicated diabetes and high cardiovascular risk, additional
% < HbA1c < 10%
no history of cardiovascular eventand diabetic nephropathy no more than stage 2 (i.e
Coronary artery calcium score > 400 (assessment < 12 months)
GFR ≥ 60 ml/min by MDRD or CKD-EPI formula and albuminuria/creatininuria ≤ 30 mg/g)
or more years of diabetes
Group 3: Patients with complicated diabetes, additional inclusion criteria are
% < HbA1c < 10%

Exclusion Criteria

Solid organ or bone marrow transplant patient
Pregnant or breastfeeding woman
Absence of free and informed consent
Non-affiliation to a social security regimen or CMU (universal health coverage)
Subject deprived of freedom, subject under a legal protective measure
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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