Status:
COMPLETED
Targeting Glutamine Metabolism to Prevent Diabetic Cardiovascular Complications
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
National Research Agency, France
Conditions:
Glutamine
Diabetic
Eligibility:
All Genders
18+ years
Brief 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 m...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria General inclusion criteria applying to the five populations are the following:
- Age above 18 years
- BMI between 25 and 40 kg/m²
- Inclusion criteria according to study group are listed below.
- Group 1: Patients with uncomplicated diabetes and low cardiovascular risk, additional inclusion criteria are:
- 5 or more years of diabetes
- 6% \< HbA1c \< 10%
- no history of cardiovascular event, diabetic microvascular complications (kidney function normal and albuminuria/creatininuria \< 30 mg/g)
- Coronary artery calcium score \< 100 (assessment \< 12 months)
- Group 2: Patients with uncomplicated diabetes and high cardiovascular risk, additional inclusion criteria are:
- 5 or more years of diabetes
- 6% \< HbA1c \< 10%
- no history of cardiovascular eventand diabetic nephropathy no more than stage 2 (i.e. GFR ≥ 60 ml/min by MDRD or CKD-EPI formula and albuminuria/creatininuria ≤ 30 mg/g)
- Coronary artery calcium score \> 400 (assessment \< 12 months)
- Group 3: Patients with complicated diabetes, additional inclusion criteria are:
- 5 or more years of diabetes
- 6% \< HbA1c \< 10%
- A history of cardiovascular event (myocardial infarction, stroke, peripheral vascular disease, or angioplasty) at least 3 months ago
- 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
Exclusion
Key Trial Info
Start Date :
November 16 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 10 2024
Estimated Enrollment :
995 Patients enrolled
Trial Details
Trial ID
NCT04353869
Start Date
November 16 2020
End Date
January 10 2024
Last Update
March 5 2025
Active Locations (2)
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1
Diabétologie - Hôpital Lariboisière
Paris, France, France, 75010
2
Diabetologie Bichat
Paris, France, France, 75018