Investigating the Relationship Between Triglycerides and Fetal Overgrowth in Gestational Diabetes

Recruiting

• Conditions: Obesity Complicating Childbirth; Gestational Diabetes; Fetal Macrosomia
• Interventions: Other: Observation

• Registration Number: NCT06067685
• Lead Sponsor: University of Kansas Medical Center

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.

Study Timeline

• Study Start: 2023-08-10
• Study First Submitted: 2023-09-20
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-02
• Last Update Submitted: 2023-10-02
• Study First Posted: 2023-10-05
• Last Update Posted: 2023-10-05
• Primary Completion: 2024-08
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnancies with GDM and BMI > 30	Observation	Pregnancies with GDM diagnosed between 24-32 weeks and BMI \> 30.

Primary Outcome Measures

Name	Time	Method
Correlation coefficient between triglyceride levels and birthweight	Newborn Day of Life 0	Correlation coefficient

Secondary Outcome Measures

Name	Time	Method
Correlation coefficient between triglyceride levels and total fat mass	0.5, 3, and 6 months	Body fat measured by air plethysmography (PeaPod)
Correlation coefficient between triglyceride levels and cord c-peptide levels	Newborn Day of Life 0	Correlation coefficient
Correlation coefficient between triglyceride levels and body fat distribution	0.5, 3, and 6 months	central vs peripheral body fat measured from DEXA scan

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States