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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Massachusetts
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Springfield, Massachusetts, Estados Unidos, 01199
- Baystate Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Gestational Diabetics
Patients with Gestational Diabetes
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|
2
Normal pregnant women without gestational diabetes
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Cholesterol
Prazo: Postpartum
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Cholesterol values were obtained at least 6 weeks postpartum from the gestational diabetic group and the normal controls
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Postpartum
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Triglyceride Values
Prazo: Postpartum
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Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.
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Postpartum
|
|
HDL
Prazo: Postpartum
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Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.
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Postpartum
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LDL
Prazo: Postpartum
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LDL values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.
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Postpartum
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Glenn R Markenson, MD, Baystate Medical Center
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB07-121
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