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Lipid Metabolism in Gestational Diabetes

NCT ID: NCT00534105

Last Updated: 2013-09-11

Study Results

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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-11-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Gestational Diabetes Hyperlipidemia

Keywords

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Pregnancy Gestational diabetes Hyperlipidemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Gestational Diabetics

Patients with Gestational Diabetes

Total Cholesterol

Intervention Type OTHER

Triglyceride

Intervention Type OTHER

HDL

Intervention Type OTHER

LDL

Intervention Type OTHER

2

Normal pregnant women without gestational diabetes

Total Cholesterol

Intervention Type OTHER

Triglyceride

Intervention Type OTHER

HDL

Intervention Type OTHER

LDL

Intervention Type OTHER

Interventions

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Total Cholesterol

Intervention Type OTHER

Triglyceride

Intervention Type OTHER

HDL

Intervention Type OTHER

LDL

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Baystate Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Glenn Markenson

Director, Maternal Fetal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Glenn R Markenson, MD

Role: PRINCIPAL_INVESTIGATOR

Baystate Medical Center

Locations

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Baystate Medical Center

Springfield, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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IRB07-121

Identifier Type: -

Identifier Source: org_study_id