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Investigating the Relationship Between Triglycerides and Fetal Overgrowth in Gestational Diabetes

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University of Kansas

Status

Terminated

Conditions

Gestational Diabetes
Obesity Complicating Childbirth
Fetal Macrosomia

Treatments

Other: Observation

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

This is a prospective, observational study which examines the association between maternal triglycerides in the antepartum period and fetal overgrowth in pregnancies complicated by gestational diabetes. Mothers are asked to provide 2 blood samples, undergo fingerstick blood measurements, and to have their newborns measured for body fat composition in the first 6 months of life.

Full description

Gestational diabetes (GDM) is a condition of impaired insulin resistance which causes increased morbidity for mothers and newborns due to fetal overgrowth. Traditionally, GDM is diagnosed with a glucose tolerance test, and treatment subsequently focuses singularly on glucose management. However, both glucose and triglycerides (TAG) are fuels for fetal overgrowth. The central hypothesis is that the most effective understanding of fetal overgrowth needs to include both carbohydrates and triglycerides. The study will focus recruitment on patients who have GDM and BMI > 35. The specific aims are 1) Determine the relationship between TAG levels during pregnancy and offspring size, 2) Explore the relationship between TAG levels during pregnancy and adipose tissue accrual (birth weight, body composition and adipose tissue distribution) from birth to six months old, and 3)Examine the relationship between maternal TAG levels and cord c-peptide levels. Mothers are asked to check their serum triglycerides at the time of diagnosis of GDM and at the end of pregnancy. Fingerstick blood measurements of triglycerides are also measured every 2 weeks at prenatal visits. At delivery, cord blood is collected. Infants are examined at 0.5, 3, and 6 months after birth.

Enrollment

7 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • singleton pregnancy
  • diagnosis of GDM between 24-32 weeks
  • BMI >= 30

Exclusion criteria

  • Conditions known to impact fetal growth.These conditions can develop after study enrollment but cannot be present at enrollment.
  • autoimmune conditions treated with medication
  • chronic hypertension requiring medication
  • preeclampsia
  • fetal growth restriction diagnosis
  • smoking
  • illicit drug use
  • major fetal anomalies
  • fetal genetic conditions

Trial design

7 participants in 1 patient group

Pregnancies with GDM and BMI > 30
Description:
Pregnancies with GDM diagnosed between 24-32 weeks and BMI \> 30.
Treatment:
Other: Observation

Trial contacts and locations

1

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Central trial contact

Gene T Lee, MD; Daniel Jalilpoor, BS

Data sourced from clinicaltrials.gov

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