Lipid Metabolism in Gestational Diabetes - Full Text View

Purpose

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

Condition	Intervention
Gestational Diabetes Hyperlipidemia	Other: Total Cholesterol Other: Triglyceride Other: HDL Other: LDL


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Study of Lipid Metabolism in Gestational Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol

U.S. FDA Resources

Further study details as provided by Baystate Medical Center:

Primary Outcome Measures:

Cholesterol [ Time Frame: Postpartum ] [ Designated as safety issue: No ]
Cholesterol values were obtained at least 6 weeks postpartum from the gestational diabetic group and the normal controls

Secondary Outcome Measures:

Triglyceride Values [ Time Frame: Postpartum ] [ Designated as safety issue: No ]
Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.
HDL [ Time Frame: Postpartum ] [ Designated as safety issue: No ]
Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.
LDL [ Time Frame: Postpartum ] [ Designated as safety issue: No ]
LDL values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.


Enrollment:	106
Study Start Date:	September 2007
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Gestational Diabetics Patients with Gestational Diabetes	Other: Total Cholesterol Other: Triglyceride Other: HDL Other: LDL
2 Normal pregnant women without gestational diabetes	Other: Total Cholesterol Other: Triglyceride Other: HDL Other: LDL

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.

Eligibility


Ages Eligible for Study:	16 Years to 40 Years (Child, Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Pregnant women

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534105

Locations


United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199

Sponsors and Collaborators

Baystate Medical Center

Investigators


Principal Investigator:	Glenn R Markenson, MD	Baystate Medical Center

More Information


Responsible Party:	Glenn Markenson, Director, Maternal Fetal Medicine, Baystate Medical Center
ClinicalTrials.gov Identifier:	NCT00534105 History of Changes
Other Study ID Numbers:	IRB07-121
Study First Received:	September 21, 2007
Results First Received:	July 2, 2013
Last Updated:	July 2, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Baystate Medical Center:


Pregnancy Gestational diabetes Hyperlipidemia

Additional relevant MeSH terms:


Diabetes Mellitus Hyperlipidemias Diabetes, Gestational Glucose Metabolism Disorders Metabolic Diseases	Endocrine System Diseases Dyslipidemias Lipid Metabolism Disorders Pregnancy Complications

ClinicalTrials.gov processed this record on September 23, 2016