- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00534105
Lipid Metabolism in Gestational Diabetes
Study of Lipid Metabolism in Gestational Diabetes
The purpose of this pilot study is to determine if, during pregnancy, women with GDM have an exaggerated lipid response compared to non-gestational diabetics. If a difference is noted, further studies will explore the possibility of screening gestational diabetics during their pregnancy for hyperlipidemia to determine if prenatal screening can predict postpartum risk for hyperlipidemia. In addition the relationship, if any between maternal lipid dysfunction and placental disease will be explored.
This will be a prospective cohort study. As part of routine prenatal care, women receive a one hour glucose challenge test to screen for gestational diabetes. Those women with elevated values then require a three hour glucose tolerance test, which is a diagnostic test for gestational diabetes. All women that are scheduled to receive a three hour GTT will be identified and ask to enroll in this study. 46 women whose three hour GTT is normal and thus do not have GDM, will be compared to 46 women with an abnormal three hour GTT and thus would have the diagnosis of GDM. Enrolled women will have a lipid panel consisting of; total cholesterol, triglycerides, HDL and LDL cholesterol at the time of their fasting glucose blood sample. In addition, a repeat lipid panel will be sent at the time of the third hour sample, to assess changes, if any due to the glucose challenge. Umbilical cord blood samples will be sent in order to obtain newborn lipid profiles. Women in both the GDM and normal groups will be asked to return 6-8 weeks
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The purpose of this pilot study is to determine if, during pregnancy, women with GDM have an exaggerated lipid response compared to non-gestational diabetics. If a difference is noted, further studies will explore the possibility of screening gestational diabetics during their pregnancy for hyperlipidemia to determine if prenatal screening can predict postpartum risk for hyperlipidemia. In addition the relationship, if any between maternal lipid dysfunction and placental disease will be explored. Subsequent studies could also explore the possible perinatal complications associated with elevated lipids and or metabolic syndrome.
C. Experimental Design, Methodology and Expected Results
Study Design:
We propose a prospective cohort design.
Study Population:
All women that are scheduled to receive a three hour GTT to rule out gestational diabetes would be identified and ask to enroll in this study. Specifically, eligible patients will be women who failed their glucose challenge test (GCT) and are scheduled for the follow-up three hour glucose tolerance test (GTT). The GCT is routinely performed among all prenatal care patients at 24-28 wks gestation. The 3 hour GTT requires patients to be fasting overnight. A fasting blood glucose is sampled, and the patients are given a 100 gram glucose drink. Serum glucose samples are then taken at one, two and three hours after the glucose loading. The "exposed" group will be defined as women diagnosed with GDM (elevated glucose values on two or more samples in the three hour GTT). The "unexposed" group will be defined as women with no abnormal glucose values in the three hour GTT.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Massachusetts
-
Springfield, Massachusetts, Estados Unidos, 01199
- Baystate Medical Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Pregnancy
- Abnormal one hour glucose challenge test
- "Normal" controls group one hour test between 135 mg% and 150 mg%
- "Gestational diabetic" group with two abnormal values on a 3 hour GTT
Exclusion Criteria:
- History of diagnosis of diabetes, hypertension, heart disease or chronic renal disease
- Prior history of lipid disorder or metabolic syndrome
- Current medications thought to adversely influence glucose tolerance (i.e. prednisone or other steroids and systemic beta-mimetic drugs)
- Non-singleton pregnancy
- < 16 years of age or over 40 years of age
- Not planning to deliver at Baystate Medical Center
- Twins
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Gestational Diabetics
Patients with Gestational Diabetes
|
|
2
Normal pregnant women without gestational diabetes
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Cholesterol
Periodo de tiempo: Postpartum
|
Cholesterol values were obtained at least 6 weeks postpartum from the gestational diabetic group and the normal controls
|
Postpartum
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Triglyceride Values
Periodo de tiempo: Postpartum
|
Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.
|
Postpartum
|
HDL
Periodo de tiempo: Postpartum
|
Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.
|
Postpartum
|
LDL
Periodo de tiempo: Postpartum
|
LDL values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.
|
Postpartum
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Glenn R Markenson, MD, Baystate Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB07-121
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Total Cholesterol
-
University Hospital Gregorio MarañónHospital del Río Hortega; Hospital de Leon; University of Navarrra Hospital (Clinica...ReclutamientoCáncer de recto | Incontinencia del esfínter analEspaña
-
Zimmer BiometTerminadoArtritis Reumatoide | Dolor de rodilla | Artrosis crónica | Necrosis avascular del cóndilo femoral | Deformidades moderadas en varo, valgo o flexiónEstados Unidos
-
Zimmer BiometActivo, no reclutandoArtritis Reumatoide | Dolor de rodilla | Artrosis crónica | Necrosis avascular del cóndilo femoral | Deformidades moderadas en varo, valgo o flexiónBélgica, Suiza, Alemania, Israel, Italia
-
Kahramanmaras Sutcu Imam UniversityTerminadoEnfermedades de la tiroides | Cáncer de tiroides | Nódulo tiroideo | Neoplasias de tiroides benignas
-
Hospital Universitario Dr. Jose E. GonzalezReclutamientoLeucemia linfoblástica agudaMéxico
-
Zimmer BiometActivo, no reclutandoOsteoartritis | Artritis Reumatoide | Artritis traumática | Dolor de rodilla crónico | Poliartritis | Necrosis avascular del cóndilo femoral | Deformidades moderadas en varo, valgo o flexiónEstados Unidos
-
Mayo ClinicTerminadoOsteoartritis de rodillaEstados Unidos
-
Klinikum der Universität KölnDesconocido
-
Maxx Orthopedics IncTerminadoDolor en las articulaciones de la rodillaEstados Unidos
-
Aesculap AGAún no reclutandoEnfermedades Articulares | Artrosis, Rodilla | Artritis reumatoide de rodilla | Artropatía postraumáticaAlemania