Investigating the Relationship Between Triglycerides and Fetal Overgrowth in Gestational Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigating the Relationship Between Triglycerides and Fetal Overgrowth in Gestational Diabetes

Conditions
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Fetal Macrosomia, Obesity Complicating Childbirth, Gestational Diabetes

Intervention / Treatment
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* Other: Observation


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnancies with GDM and BMI > 30<br>Pregnancies with GDM diagnosed between 24-32 weeks and BMI > 30. | Other: Observation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation coefficient between triglyceride levels and birthweight | Correlation coefficient | Newborn Day of Life 0 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fetal macrosomia, large for gestational age infant, gestational diabetes, maternal obesity, triglycerides, fatty acids, fetal overgrowth