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Lipid Metabolism in Gestational Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Baystate Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Baystate Medical Center
ClinicalTrials.gov Identifier:
NCT00534105
First received: September 21, 2007
Last updated: November 30, 2010
Last verified: November 2010
History of Changes
  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: lipid blood testing

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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Diabetes
U.S. FDA Resources

Further study details as provided by Baystate Medical Center:

Estimated Enrollment: 92
Study Start Date: September 2007
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients with Gestational Diabetes
 Other: lipid blood testing

Measurement of total cholesterol, triglycerides, HDL and LDL cholesterol will be sent before and after a three hour glucose tolerance test.

Umbilical cord blood samples will be sent in order to obtain newborn lipid profiles.
2
Normal pregnant women without gestational diabetes
 Other: lipid blood testing

Measurement of total cholesterol, triglycerides, HDL and LDL cholesterol will be sent before and after a three hour glucose tolerance test.

Umbilical cord blood samples will be sent in order to obtain newborn lipid profiles.

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
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
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

No publications provided

Responsible Party: Glenn Markenson, MD, Baystate Medical Center
ClinicalTrials.gov Identifier: NCT00534105     History of Changes
Other Study ID Numbers: IRB07-121
Study First Received: September 21, 2007
Last Updated: November 30, 2010
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 May 16, 2013