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NCT00534105 · ClinicalTrials.gov registry record
Lipid Metabolism in Gestational Diabetes
A clinical trial, sponsored by Baystate Medical Center.
- Completed
- Registry status
- 106
- Enrollment target
NCT00534105 is a clinical trial that has completed, run by Baystate Medical Center. The registered enrollment target is 106 participants.
The verdict
NCT00534105 has completed, sponsored by Baystate Medical Center.
- COMPLETED
- Registry status
- 106 participants
- Enrollment target
Study Summary
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
Interventions
- OTHER Total Cholesterol
- OTHER Triglyceride
- OTHER HDL
- OTHER LDL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2007-09 |
| Est. Completion | 2010-11 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00534105
The ClinicalTrials.gov registry entry for NCT00534105 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baystate Medical Center, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Total Cholesterol is the first listed.
NCT00534105 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00534105 about?
NCT00534105 is a clinical study titled "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 hyperlip...
What is the current status of trial NCT00534105?
This trial is currently completed. The enrollment target is 106 participants. The study started on 2007-09. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00534105?
The interventions under investigation include: Total Cholesterol (OTHER), Triglyceride (OTHER), HDL (OTHER), LDL (OTHER).
Who is sponsoring clinical trial NCT00534105?
This trial is sponsored by Baystate Medical Center, which has 36 total clinical trials registered on ClinicalTrials.gov.
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