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Lipid Metabolism in Gestational Diabetes

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ClinicalTrials.gov Identifier: NCT00534105
Recruitment Status : Completed
First Posted : September 24, 2007
Results First Posted : September 11, 2013
Last Update Posted : September 11, 2013
Sponsor:
Information provided by (Responsible Party):
Glenn Markenson, Baystate Medical Center

Study Description
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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


Condition or disease Intervention/treatment
Gestational Diabetes Hyperlipidemia 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.


Study Design
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Study Type : Observational
Actual Enrollment : 106 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Lipid Metabolism in Gestational Diabetes
Study Start Date : September 2007
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Cholesterol [ Time Frame: Postpartum ]
    Cholesterol values were obtained at least 6 weeks postpartum from the gestational diabetic group and the normal controls


Secondary Outcome Measures :
  1. Triglyceride Values [ Time Frame: Postpartum ]
    Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.

  2. HDL [ Time Frame: Postpartum ]
    Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.

  3. LDL [ Time Frame: Postpartum ]
    LDL values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Glenn Markenson, Director, Maternal Fetal Medicine, Baystate Medical Center
ClinicalTrials.gov Identifier: NCT00534105     History of Changes
Other Study ID Numbers: IRB07-121
First Posted: September 24, 2007    Key Record Dates
Results First Posted: September 11, 2013
Last Update Posted: September 11, 2013
Last Verified: July 2013

Keywords provided by Glenn Markenson, Baystate Medical Center:
Pregnancy
Gestational diabetes
Hyperlipidemia

Additional relevant MeSH terms:
Diabetes Mellitus
Hyperlipidemias
Hyperlipoproteinemias
Diabetes, Gestational
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Pregnancy Complications