Investigating the Relationship Between Triglycerides and Fetal Overgrowth in Gestational Diabetes

Gestational Diabetes Clinical Trial

Official title:

Investigating the Relationship Between Triglycerides and Fetal Overgrowth in Gestational Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06067685
• Other study ID #: 150494
• Status: Recruiting
• Start date: August 10, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: October 2023
• Source: University of Kansas Medical Center
• Contact: Gene T Lee, MD
• Phone: 913 588 6201
• Email: glee[@]kumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: August 1, 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Fetal Macrosomia
• Gestational Diabetes
• Obesity Complicating Childbirth

Intervention

Other:
• Observation
Prospective Observation only. Will record serum triglyceride, fingerstick blood triglyceride measurements, cord c-peptide, and neonatal body fat composition measurements in the first 6 months.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation coefficient between triglyceride levels and birthweight	Correlation coefficient	Newborn Day of Life 0
Secondary	Correlation coefficient between triglyceride levels and total fat mass	Body fat measured by air plethysmography (PeaPod)	0.5, 3, and 6 months
Secondary	Correlation coefficient between triglyceride levels and body fat distribution	central vs peripheral body fat measured from DEXA scan	0.5, 3, and 6 months
Secondary	Correlation coefficient between triglyceride levels and cord c-peptide levels	Correlation coefficient	Newborn Day of Life 0