Gestational Diabetes, Hyperlipidemia
Conditions
Keywords
Pregnancy, Gestational diabetes, Hyperlipidemia
Brief 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
Detailed description
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.
Interventions
Sponsors
Baystate Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cholesterol | Postpartum | Cholesterol values were obtained at least 6 weeks postpartum from the gestational diabetic group and the normal controls |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Triglyceride Values | Postpartum | Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls. |
| HDL | Postpartum | Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls. |
| LDL | Postpartum | LDL values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls. |
Countries
United States
Participant flow
Recruitment details
Pregnant patients presenting for gestational diabetes screening
Pre-assignment details
Only uncomplicated obstetrical patients
Participants by arm
| Arm | Count |
|---|---|
| Gestational Diabetics Patients with Gestational Diabetes with a lipid screening performed during the pregnancy. | 47 |
| Normal Pregnancies Normal pregnant women without gestational diabetes | 59 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 23 | 39 |
Baseline characteristics
| Characteristic | Gestational Diabetics | Normal Pregnancies | Total |
|---|---|---|---|
| Age Continuous Age at Recruitment | 32 years | 30 years | 31 years |
| Region of Enrollment United States | 47 participants | 59 participants | 106 participants |
| Sex: Female, Male Female | 47 Participants | 59 Participants | 106 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 47 | 0 / 59 |
| serious Total, serious adverse events | 0 / 47 | 0 / 59 |
Outcome results
Primary
Cholesterol
Cholesterol values were obtained at least 6 weeks postpartum from the gestational diabetic group and the normal controls
Time frame: Postpartum
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Gestational Diabetics | Cholesterol | 204 mg/dl |
| Normal Pregnancies | Cholesterol | 201 mg/dl |
Secondary
HDL
Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.
Time frame: Postpartum
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Gestational Diabetics | HDL | 51 mg/dl |
| Normal Pregnancies | HDL | 57 mg/dl |
Secondary
LDL
LDL values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.
Time frame: Postpartum
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Gestational Diabetics | LDL | 124 mg/dl |
| Normal Pregnancies | LDL | 120 mg/dl |
Secondary
Triglyceride Values
Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.
Time frame: Postpartum
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Gestational Diabetics | Triglyceride Values | 118 mg/dl |
| Normal Pregnancies | Triglyceride Values | 83 mg/dl |