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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gestational Diabetics | Patients with Gestational Diabetes |
| |
| 2 | Normal pregnant women without gestational diabetes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Cholesterol | Other |
| ||
| Triglyceride |
| Measure | Description | Time Frame |
|---|---|---|
| Cholesterol | Cholesterol values were obtained at least 6 weeks postpartum from the gestational diabetic group and the normal controls | Postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Triglyceride Values | Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls. | Postpartum |
| HDL | Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls. |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Glenn R Markenson, MD | Baystate Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
Only uncomplicated obstetrical patients
Pregnant patients presenting for gestational diabetes screening
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| ID | Title | Description |
|---|---|---|
| FG000 | Gestational Diabetics | Patients with Gestational Diabetes with a lipid screening performed during the pregnancy. |
| FG001 | Normal Pregnancies | Normal pregnant women without gestational diabetes |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gestational Diabetics | Patients with Gestational Diabetes with a lipid screening performed during the pregnancy. |
| BG001 | Normal Pregnancies | Normal pregnant women without gestational diabetes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cholesterol | Cholesterol values were obtained at least 6 weeks postpartum from the gestational diabetic group and the normal controls | Posted | Mean | Inter-Quartile Range | mg/dl | Postpartum |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gestational Diabetics | Patients with Gestational Diabetes with a lipid screening performed during the pregnancy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Glenn Markenson MD | Baystate Medical Center | 413-794-8073 | glenn.markenson@bhs.org |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D002784 | Cholesterol |
| D014280 | Triglycerides |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Other |
|
| HDL | Other |
|
| LDL | Other |
|
| Postpartum |
| LDL | LDL values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls. | Postpartum |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Triglyceride Values | Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls. | Posted | Mean | Inter-Quartile Range | mg/dl | Postpartum |
|
|
|
| Secondary | HDL | Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls. | Posted | Mean | Inter-Quartile Range | mg/dl | Postpartum |
|
|
|
| Secondary | LDL | LDL values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls. | Posted | Mean | Inter-Quartile Range | mg/dl | Postpartum |
|
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | Normal Pregnancies | Normal pregnant women without gestational diabetes | 0 | 59 | 0 | 59 |
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D005989 | Glycerides |