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Postpartum Glycemia in Women At Risk for Persistent Hyperglycemia 40 Pós-parto

Concluído
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O estudo clínico NCT04521712 foi um estudo intervencionista para Diabetes gestacional. Seu status atual é: concluído. O estudo começou em 17 de setembro de 2021 e incluiu 40 participantes. Coordenado por a Universidade do Alabama em Birmingham e foi concluído em 10 de dezembro de 2024. Essas informações foram atualizadas no ClinicalTrials.gov em 18 de dezembro de 2024.
Resumo
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...Mostrar mais
Título oficial

Postpartum Glycemia in Women At Risk for Persistent Hyperglycemia

Condições médicas
Diabetes gestacional
Publicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:
Outros IDs do estudo
  • 300005510
Número NCT
NCT04521712
Data de início (real)
2021-09-17
Última atualização postada
2024-12-18
Data de conclusão (estimada)
2024-12-10
Inscrição (estimada)
40
Tipo de estudo
Intervencionista
FASE
N/A
Status
Concluído
Propósito principal
Diagnóstico
Alocação do design
N/A
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
ExperimentalPostpartum 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...Mostrar mais
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
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
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
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
Critérios de elegibilidade

Idades elegíveis
Adulto
Idade mínima
18 Years
Sexos elegíveis
Feminino
  • 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 logoUniversidade do Alabama em Birmingham478 estudos clínicos ativos para explorar
University of North Carolina, Chapel Hill logoUniversidade da Carolina do Norte em Chapel Hill241 estudos clínicos ativos para explorar
Responsável pelo estudo
Ashley N. Battarbee, Investigador principal, Assistant Professor, University of Alabama at Birmingham
Sem dados de contato.
2 Locais do estudo em 1 países

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