Lipid Metabolism in Gestational Diabetes

Gestational Diabetes Clinical Trial

Official title:

Study of Lipid Metabolism in Gestational Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534105
• Other study ID #: IRB07-121
• Status: Completed
• Phase: N/A
• First received: September 21, 2007
• Last updated: July 2, 2013
• Start date: September 2007
• Est. completion date: November 2010

Study information

• Verified date: July 2013
• Source: Baystate Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 40 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Hyperlipidemia
• Hyperlipidemias

Intervention

Other:
• Total Cholesterol

• Triglyceride

• HDL

• LDL

Locations

Country	Name	City	State
United States	Baystate Medical Center	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Baystate Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cholesterol	Cholesterol values were obtained at least 6 weeks postpartum from the gestational diabetic group and the normal controls	Postpartum	No
Secondary	Triglyceride Values	Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.	Postpartum	No
Secondary	HDL	Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.	Postpartum	No
Secondary	LDL	LDL values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.	Postpartum	No