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Postpartum Glycemia in Women At Risk for Persistent Hyperglycemia 40 Post-partum

Terminé
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT04521712 a été une étude interventionnel pour Diabète gestationnel. Son statut actuel est : terminé. L'étude a commencé le 17 septembre 2021, avec un objectif de recruter 40 participants. Dirigée par l'Université de l'Alabama à Birmingham, l'étude s'est terminée le 10 décembre 2024. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 18 décembre 2024.
Résumé succinct
GDM is characterized by decreased insulin sensitivity, decreased insulin secretion, or a combination of both. Women with GDM are at significant risk for overt T2DM later in life, and postpartum insulin sensitivity and secretion in women with GDM has not been quantified, limiting our ability to optimize screening for overt T2DM. In addition, compliance with currently recommended postpartum T2DM screening by OGTT is po...Afficher plus
Titre officiel

Postpartum Glycemia in Women At Risk for Persistent Hyperglycemia

Pathologies
Diabète gestationnel
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'étude
  • 300005510
Numéro NCT
NCT04521712
Date de début (réel)
2021-09-17
Dernière mise à jour publiée
2024-12-18
Date de fin (estimée)
2024-12-10
Inscription (estimée)
40
Type d'étude
Interventionnel
PHASE
N/A
Statut
Terminé
Objectif principal
Diagnostic
Méthode d'allocation
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalPostpartum GDM
Women with GDM diagnosed early (\< 20 weeks gestation) or with routine 3rd trimester screening (\>=24 weeks) will be enrolled in this longitudinal study. All enrolled women will complete a oral glucose tolerance test and wear a continuous glucose monitor for 10 days at the 3 designated study time points (0-4 days, 4-6 weeks, and 6 months after delivery).
2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor
All women enrolled in this study will have a 2-hour 75-g oral glucose tolerance test performed immediately postpartum (within 4 days of delivery), at 4-6 weeks postpartum, and at 6 months postpartum. Enrolled women will also wear a continuous glucose monitor for 10 days at each of these time periods. Both women and their infants will have skin fold thickness measured at each of these 3 study visits to estimate body f...Afficher plus
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
Pancreatic beta cell function
Insulin secretion will be estimated using the Stomvall index and insulin sensitivity using the Matsuda index.
4-6 weeks after delivery
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
Maternal glycemia measured by CGM
% time in range
10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery
Maternal hyperglycemia measured by CGM
% time above range
10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery
Maternal glucose variability
Coefficient of variation (glucose standard deviation/mean glucose)
10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery
Pancreatic beta cell function
Insulin secretion will be estimated using the Stomvall index and insulin sensitivity using the Matsuda index.
0-4 days and 6 months after delivery
Maternal and infant body fat composition
Percentage body fat calculated from skin fold thickness measurements of upper mid-arm, triceps, subscapular, and flank along with height and weight for the mother and length, birthweight and head circumference for the infant.
0-4 days, 4-6 weeks, and 6 months after delivery
Maternal diabetes mellitus
Fasting blood glucose \>= 126mg/dL or 2-hour blood glucose \>=200 mg/dL after 75g oral glucose load.
4-6 weeks and 6 months after delivery
Critères d'éligibilité

Âges éligibles
Adulte
Âge minimum
18 Years
Sexes éligibles
Femme
  • Live singleton gestation with no fetal anomalies at 34-40 weeks gestation
  • Gestational diabetes mellitus identified at < 20 weeks' gestation requiring pharmacologic treatment (class A2)

  • History of prediabetes or polycystic ovarian syndrome
  • History of pregestational type 2 diabetes mellitus
  • Skin conditions which prevent wearing a continuous glucose monitor

Inclusion Criteria for 3rd trimester GDM women:

  • Live singleton gestation with no fetal anomalies at 34-40 weeks gestation
  • Gestational diabetes mellitus identified at >= 24 weeks' gestation requiring pharmacologic treatment (class A2)

Exclusion Criteria for 3rd trimester GDM women:

  • History of prediabetes or polycystic ovarian syndrome
  • History of pregestational type 2 diabetes mellitus
  • Skin conditions which prevent wearing a continuous glucose monitor
University of Alabama at Birmingham logoUniversité de l'Alabama à Birmingham478 essais cliniques actifs à explorer
University of North Carolina, Chapel Hill logoUniversité de Caroline du Nord à Chapel Hill241 essais cliniques actifs à explorer
Partie responsable de l'étude
Ashley N. Battarbee, Investigateur principal, Assistant Professor, University of Alabama at Birmingham
Aucune donnée de contact disponible
2 Centres de l'étude dans 1 pays

Alabama

University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States

North Carolina

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27514, United States