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- Essai clinique NCT07564752
The Effect of Improved Glycemic Control on the Composition and Function of High-Density Lipoproteins (HDL) in Patients With Type 1 Diabetes (HAGI-T1D)
Effect of Improved Glycemic Control on the Composition and Function of High-density Lipoproteins (HDL) in Patients With Type 1 Diabetes: a Prospective, Single-center Study. Comparison With Non-diabetic, Non-dyslipidemic Control Subjects. - HAGI-T1D Study
The HAGI-T1D study aims to determine the effect of improved glycemic control on the composition and function of high-density lipoproteins (HDL) in patients with type 1 diabetes (T1D). It requires the establishment of a biological plasma/serum bank.
T1D patients hospitalized in the Endocrinology-Diabetology-Metabolic Diseases Department at the Dijon Bourgogne University Hospital for poorly controlled diabetes (defined by glycated hemoglobin HbA1c >8.0%).
The study includes a T1D group of 80 patients with unsatisfactory glycemic control, who will undergo intensified therapy in accordance with standard clinical practice (modification of insulin therapy, therapeutic education, and lifestyle and dietary guidelines). The study also includes a control group of 63 non-diabetic, non-dyslipidemic subjects enrolled based on the results of laboratory tests from the screening visit to assess whether improved glycemic control in the T1D group restores anti-atherogenic functions and HDL composition to a level comparable to that of the control group.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Benjamin BOUILLET
- Numéro de téléphone: 03 80 29 34 53
- E-mail: benjamin.bouillet@chu-dijon.fr
Lieux d'étude
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Dijon, France
- Recrutement
- CHU Dijon Bourgogne
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Contact:
- Benjamin BOUILLET
- Numéro de téléphone: 03 80 29 34 53
- E-mail: benjamin.bouillet@chu-dijon.fr
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
Control group non-diabetic and non-dyslipidemic :
- A person who has giver written consent
- Fasting blood glucose < 1,10 g/L
- Triglycerides < 1,50 g/L (< 1,70 mmol/L).
- HDL cholesterol > 1,03 mmol/L (men) or > 1,30 mmol/L (women).
- LDL cholesterol < 1,60 g/L.
Type 1 diabetes group :
- A person who has giver written consent
- Treated type 1 diabetes (regardless of the route of insulin administration).
- HbA1c > 8.0% (> 64 mmol/mol).
Exclusion Criteria:
All participants :
- A person who is not enrolled in or eligible for a social security program
- A person subject to a legal protective measure (guardianship, tutorship)
- A person subject to a judicial protective measure
- Pregnant women, women in labor, or breastfeeding women
- Adults who are legally incompetent or unable to give informed consent
- Minors
- Systemic inflammatory disease
- Medications that affect lipoprotein metabolism: immunosuppressive therapy, long-term corticosteroid therapy.
Control group non-diabetic and non-dyslipidemic :
- Diabetes or use of an antidiabetic medication.
- Dyslipidemia or use of lipid-lowering medication.
- Cardiovascular disease (history of stroke, myocardial infarction, coronary artery disease).
- Kidney disease (glomerular filtration rate CKD-EPI < 75 mL/min/1.73 m²)
Presence of metabolic syndrome defined by the presence of at least three of the following criteria (NCEP-ATP III criteria):
- waist circumference > 102 cm in men, > 88 cm in women;
- fasting triglycerides > 1.70 mmol/L ( > 1.50 g/L);
- HDL cholesterol > 1.03 mmol/L in men and 1.29 mmol/L in women;
- systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 85 mmHg;
- fasting blood glucose ≥ 6.10 mmol/L (≥ 1.10 g/L).
Type 1 diabetes group:
- Diagnosis of type 1 diabetes within 12 months prior to enrollment.
- Glomerular filtration rate (CKD-EPI) < 60 mL/min/1.73 m².
- Albuminuria ≥ 30 mg/g creatinine.
- Initiation of lipid-lowering therapy within the month prior to the study.
Exclusion criteria:
Type 1 diabetes group:
- Initiation of lipid-lowering therapy during the 3 months of the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Patients with type 1 diabetes
Patients hospitalized in the Endocrinology, Diabetes, and Metabolic Diseases Department at the Dijon Bourgogne University Hospital due to poorly controlled diabetes.
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Performed on an empty stomach at the initial visit and then at 3 months
Performed only during the initial visit for patients with type 1 diabetes
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Control
Patients who are neither diabetic nor hypoglycemic
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Performed on an empty stomach at the initial visit and then at 3 months
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Difference in the percentage of HDL-induced stimulation of eNOS activation via phosphorylation at serine 1177 in human HUVEC endothelial cells
Délai: Between Month 0 and Month 3
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Between Month 0 and Month 3
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système endocrinien
- Maladies métaboliques
- Maladies auto-immunes
- Maladies du système immunitaire
- Troubles du métabolisme du glucose
- Diabète sucré
- Maladies nutritionnelles et métaboliques
- Diabète sucré, type 1
- Techniques d'investigation
- Techniques de laboratoire clinique
- Techniques et procédures de diagnostic
- Diagnostic
- Tests hématologiques
Autres numéros d'identification d'étude
- DENIMAL AOI 2023
Informations sur les médicaments et les dispositifs, documents d'étude
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