Clinical trial NCT06067685: Investigating the Relationship Between Triglycerides and Fetal Overgrowth in Gestational Diabetes
Official title: Investigating the Relationship Between Triglycerides and Fetal Overgrowth in Gestational Diabetes
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Fetal Macrosomia
Obesity Complicating Childbirth
Gestational Diabetes
Keywords: fetal macrosomia
large for gestational age infant
gestational diabetes
maternal obesity
triglycerides
fatty acids
fetal overgrowth
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving prenatal care and planning to delivery at the University of Kansas Health System. Population includes significant numbers of Black and Hispanic patients. Population also includes significant numbers of self-pay and government-insured patients.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation coefficient between triglyceride levels and birthweight
timeFrame: Newborn Day of Life 0
Secondary outcomes:
measure: Correlation coefficient between triglyceride levels and total fat mass
timeFrame: 0.5, 3, and 6 months
measure: Correlation coefficient between triglyceride levels and body fat distribution
timeFrame: 0.5, 3, and 6 months
measure: Correlation coefficient between triglyceride levels and cord c-peptide levels
timeFrame: Newborn Day of Life 0
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Gene T Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: