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- Essai clinique NCT06273631
Effet des modifications de l'apport en glucides sur le contrôle de la glycémie chez les patients atteints de diabète de type 1
Effet des modifications de l'apport en glucides sur le contrôle de la glycémie chez les patients atteints de diabète de type 1.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
1. Objectif principal : évaluer l'effet des modifications de l'apport en glucides sur le contrôle de la glycémie chez les patients atteints de diabète de type 1.
- Critère principal : différence de temps dans la plage (TIR) entre les 2 groupes.
- Critère secondaire :
1) différence de coefficient de variation (CV), amplitude moyenne des excursions glycémiques (MAGE), grande amplitude des excursions glycémiques (LAGE) entre les 2 groupes ; 2) différence de variation de l'HbA1c,GA,1,5-anhydroglucitol (1,5-AG) par rapport à la valeur initiale entre les 2 groupes ; 3) différence de changement dans l'incidence des événements hypoglycémiques (%), des hypoglycémies sévères et des événements d'hypoglycémie nocturne par rapport au départ entre les 2 groupes ; 4) différence de changement de dose d'insuline (UI/kg/jour) par rapport à la valeur initiale entre les 2 groupes.
2. Objectif secondaire : explorer le mécanisme possible d'intervention diététique pour améliorer le contrôle de la glycémie chez les patients atteints de diabète de type 1.
- Effets d'une intervention diététique sur le microenvironnement intestinal et la microflore des patients diabétiques de type 1 ;
- Effets d'une intervention diététique sur la fonction immunitaire des patients diabétiques de type 1 ;
- Effets de l'intervention diététique sur la métabolomique des patients diabétiques de type 1.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Tao Yang, MD/PhD
- Numéro de téléphone: 6466 86-25-83718836
- E-mail: yangt@njmu.edu.cn
Lieux d'étude
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Jiangsu
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Nanjing, Jiangsu, Chine, 210029
- Recrutement
- First Affiliated Hospital, Nanjing Medical University
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Contact:
- Tao Yang, PhD
- Numéro de téléphone: 6466 86-25-83718836
- E-mail: yangt@njmu.edu.cn
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Critère d'intégration:
- Ceux qui acceptent de participer à l'étude et signent un consentement éclairé ;
- Diagnostic du diabète sucré de type 1 (ADA2024) ;
- Âge de 18 à 65 ans ;
- Dépendant de l'insulinothérapie exogène (CSII), le plan de traitement reste inchangé dans les 2 mois (le type d'insuline ne peut pas être modifié, et la dose peut être ajustée en fonction de la glycémie) ;
- Indice de masse corporelle (IMC) de 18 à 24 kg/m2 ;
- HbA1c ≤9,5 % ;
- Peptide C aléatoire ≥200pmol/L.
Critère d'exclusion:
- Les jeunes mariés atteints de diabète sucré de type 1 ;
- Les femmes enceintes ou envisageant de le devenir ;
- Les patients végétariens ;
- Patients utilisateurs d'hypoglycémiants oraux (inhibiteurs de l'alpha-glucosidase, inhibiteurs de la DPP-IV, etc.) ;
- Patients qui utilisent des glucocorticoïdes dans les 30 jours ;
- Antécédents d'allergie alimentaire sévère ;
- Patients présentant des complications aiguës telles que l'ACD ;
- Patients souffrant de gastroparésie, de maladie inflammatoire de l'intestin et d'autres complications ;
- Patients présentant une albuminurie importante et une insuffisance rénale ;
- Patients présentant une hyperthyroïdie et une hypothyroïdie incontrôlée ;
- Antécédents de maladie cardiaque, de maladie coronarienne et d'arythmie ;
- Grave dysfonctionnement hépatique (ALT ou AST> 1,5 fois la limite supérieure de la normale) ;
- Antécédents de tumeurs malignes, autres maladies incontrôlées du système immunitaire, infections incontrôlées ;
- Abus d'alcool, troubles mentaux ou autres conditions inaptes à être observateur lors de tests de dépistage de drogues ;
- Patients atteints de toute maladie susceptible d'interférer avec la participation ou l'évaluation à l'étude.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: diverse carbohydrate diet
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively. Of the staple carbohydrate sources, 45-50% are derived from refined grains and 45-50% from whole grains and legumes. Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%. |
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively.
Of the staple carbohydrate sources, 45-50% are derived from refined grains and 45-50% from whole grains and legumes.
Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%.
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|
Autre: moderate carbohydrate diet
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively. Of the staple carbohydrate sources, 90-95% are derived from refined grains. Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%. |
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively.
Of the staple carbohydrate sources, 90-95% are derived from refined grains.
Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Time in range (TIR)
Délai: 4 weeks (2 weeks after randomization)
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TIR is defined as the percentage of time that glucose levels are between 3.9 and 10.0 mmol/L, as measured by continuous glucose monitoring (CGM).
TIR at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Time above range(TAR)
Délai: 4 weeks (2 weeks after randomization)
|
TAR is defined as the percentage of time that glucose levels are above 10.0 mmol/L, as measured using continuous glucose monitoring (CGM).
TAR at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Time below range(TBR)
Délai: 4 weeks (2 weeks after randomization)
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TBR is defined as the percentage of time that glucose levels are below 3.9 mmol/L, as measured using continuous glucose monitoring (CGM).
TBR at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Mean glucose (MG)
Délai: 4 weeks (2 weeks after randomization)
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Mean glucose is defined as the arithmetic mean of all valid glucose values recorded during the 2-week continuous glucose monitoring (CGM) period.
Mean glucose at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Standard deviation of glucose (SD)
Délai: 4 weeks (2 weeks after randomization)
|
SD is a continuous glucose monitoring (CGM)-derived measure of glycemic variability.
SD at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Glucose coefficient of variation (CV)
Délai: 4 weeks (2 weeks after randomization)
|
CV is a continuous glucose monitoring (CGM)-derived measure of glycemic variability.
CV at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Mean amplitude of glycemic excursions (MAGE)
Délai: 4 weeks (2 weeks after randomization)
|
MAGE is a continuous glucose monitoring (CGM)-derived measure of glycemic variability.
MAGE at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Largest amplitude of glycemic excursions (LAGE)
Délai: 4 weeks (2 weeks after randomization)
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LAGE is a continuous glucose monitoring (CGM)-derived measure of glycemic variability.
LAGE at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Glycated albumin (GA)
Délai: 4 weeks (2 weeks after randomization)
|
Glycated albumin will be measured at the end of the 2-week dietary intervention and compared between the two groups.
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4 weeks (2 weeks after randomization)
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Glycated hemoglobin A1c (HbA1c)
Délai: 16 weeks (14 weeks after randomization)
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HbA1c will be measured at the end of the follow-up period and compared between the two groups.
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16 weeks (14 weeks after randomization)
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C-peptide area under the curve (AUC C-peptide)
Délai: 16 weeks (14 weeks after randomization)
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C-peptide area under the curve will be assessed during a 3-hour mixed-meal tolerance test and calculated using the trapezoidal rule.
The assessment will be performed in participants with fasting C-peptide >80 pmol/L.
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16 weeks (14 weeks after randomization)
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Glucagon area under the curve (AUC glucagon)
Délai: 16 weeks (14 weeks after randomization)
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Glucagon area under the curve will be assessed during a 3-hour mixed-meal tolerance test and calculated using the trapezoidal rule.
The assessment will be performed in participants with fasting C-peptide >80 pmol/L.
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16 weeks (14 weeks after randomization)
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Fasting blood glucose (FBG)
Délai: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Fasting blood glucose will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Total cholesterol (TC)
Délai: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Total cholesterol will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Triglycerides (TG)
Délai: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Triglycerides will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Low-density lipoprotein cholesterol (LDL-C)
Délai: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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LDL-C will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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High-density lipoprotein cholesterol (HDL-C)
Délai: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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HDL-C will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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1,5-Anhydroglucitol (1,5-AG)
Délai: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
1,5-AG will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Total daily insulin dose
Délai: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Total daily insulin dose, expressed as IU/kg/day, will be assessed at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Basal insulin dose
Délai: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Basal insulin dose, expressed as IU/kg/day, will be assessed at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Prandial insulin dose
Délai: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Prandial insulin dose, expressed as IU/kg/day, will be assessed at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Body weight
Délai: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Body weight will be measured at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Waist circumference
Délai: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Waist circumference will be measured at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Hip circumference
Délai: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Hip circumference will be measured at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Waist-to-hip ratio (WHR)
Délai: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Waist-to-hip ratio will be calculated from waist and hip circumference measurements at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Body composition
Délai: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Body composition will be assessed using a body composition analyzer at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Hypoglycemic events
Délai: From randomization to the end of follow-up at 16 weeks
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Hypoglycemic events will be assessed by the number of events per participant, the proportion of participants experiencing at least one hypoglycemic event, and the incidence rate of hypoglycemic events.
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From randomization to the end of follow-up at 16 weeks
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Diabetic ketoacidosis (DKA)
Délai: From randomization to the end of follow-up at 16 weeks
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The number and proportion of participants experiencing diabetic ketoacidosis will be assessed and compared between the two groups.
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From randomization to the end of follow-up at 16 weeks
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Gut microbiota profile
Délai: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Gut microbiota profiles will be assessed from fecal samples at the end of the dietary intervention and at the end of the follow-up period to evaluate differences between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Metabolomic profile
Délai: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Metabolomic profiles will be assessed at the end of the dietary intervention and at the end of the follow-up period to evaluate differences between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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T-cell subset proportions
Délai: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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The proportions of T-cell subsets will be assessed by flow cytometry at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Tao Yang, MD/PhD, First Affiliated Hospital, Nanjing Medical University, China
Publications et liens utiles
Publications générales
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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
Autres numéros d'identification d'étude
- 2022-SR-481.A3
Informations sur les médicaments et les dispositifs, documents d'étude
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