Investigating the Relationship Between Triglycerides and Fetal Overgrowth in Gestational Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-10

Study Completion Date

2024-09-01

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.

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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.

Conditions

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Fetal Macrosomia Obesity Complicating Childbirth Gestational Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnancies with GDM and BMI > 30

Pregnancies with GDM diagnosed between 24-32 weeks and BMI \> 30.

Observation

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes