Lipid Metabolism in Gestational Diabetes

NCT00534105 | Completed Results

• 1 other identifier: IRB07-121
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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

Conditions

Gestational Diabetes; Hyperlipidemia

Keywords

Pregnancy; Gestational diabetes; Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Cholesterol

  Cholesterol values were obtained at least 6 weeks postpartum from the gestational diabetic group and the normal controls

  Postpartum

Secondary Outcomes (3)

• Triglyceride Values

  Postpartum

• HDL

  Postpartum

• LDL

  Postpartum

Study Arms (2)

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

Interventions

Total Cholesterol OTHER

2; Gestational Diabetics

Triglyceride OTHER

2; Gestational Diabetics

HDL OTHER

2; Gestational Diabetics

LDL OTHER

2; Gestational Diabetics

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baystate Medical Center: lead

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Hyperlipidemias

Interventions

Cholesterol; Triglycerides

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Membrane Lipids; Lipids; Glycerides

Results Point of Contact

• Title: Glenn Markenson MD
• Organization: Baystate Medical Center

glenn.markenson@bhs.org

413-794-8073

Study Officials

• Glenn R Markenson, MD

  Baystate Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Maternal Fetal Medicine

Study Record Dates

• First Submitted: September 21, 2007
• First Posted: September 24, 2007
• Study Start: September 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: September 11, 2013
• Results First Posted: September 11, 2013

Record last verified: 2013-07

Locations

US (1)