Investigating the Relationship Between Triglycerides and Fetal Overgrowth in Gestational Diabetes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pregnancies with GDM and BMI > 30 Pregnancies with GDM diagnosed between 24-32 weeks and BMI > 30. |
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.
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Outcome Measures
Primary Outcome Measures
- Correlation coefficient between triglyceride levels and birthweight [Newborn Day of Life 0]
Correlation coefficient
Secondary Outcome Measures
- 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 body fat distribution [0.5, 3, and 6 months]
central vs peripheral body fat measured from DEXA scan
- Correlation coefficient between triglyceride levels and cord c-peptide levels [Newborn Day of Life 0]
Correlation coefficient
Eligibility Criteria
Criteria
Inclusion Criteria:
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singleton pregnancy
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diagnosis of GDM between 24-32 weeks
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BMI >= 30
Exclusion Criteria:
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Conditions known to impact fetal growth.These conditions can develop after study enrollment but cannot be present at enrollment.
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autoimmune conditions treated with medication
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chronic hypertension requiring medication
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preeclampsia
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fetal growth restriction diagnosis
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smoking
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illicit drug use
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major fetal anomalies
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fetal genetic conditions
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
Sponsors and Collaborators
- University of Kansas Medical Center
Investigators
- Principal Investigator: Gene T Lee, MD, University of Kansas Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 150494