Investigating the Relationship Between Triglycerides and Fetal Overgrowth in Gestational Diabetes

NCT06067685 | Terminated

• 1 other identifier: 150494
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Macrosomia; Obesity Complicating Childbirth; Gestational Diabetes

Keywords

fetal macrosomia; large for gestational age infant; gestational diabetes; maternal obesity; triglycerides; fatty acids; fetal overgrowth

Outcome Measures

Primary Outcomes (1)

• Correlation coefficient between triglyceride levels and birthweight

  Correlation coefficient

  Newborn Day of Life 0

Secondary Outcomes (3)

• Correlation coefficient between triglyceride levels and total fat mass

  0.5, 3, and 6 months

• Correlation coefficient between triglyceride levels and body fat distribution

  0.5, 3, and 6 months

• Correlation coefficient between triglyceride levels and cord c-peptide levels

  Newborn Day of Life 0

Study Arms (1)

Pregnancies with GDM and BMI > 30

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

Other: Observation

Interventions

Observation 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.

Pregnancies with GDM and BMI > 30

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving prenatal care and planning to delivery at the University of Kansas Health System. Population includes significant numbers of Black and Hispanic patients. Population also includes significant numbers of self-pay and government-insured patients.

You may qualify if:

• singleton pregnancy
• diagnosis of GDM between 24-32 weeks
• BMI \>= 30

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

cord serum

MeSH Terms

Conditions

Fetal Macrosomia; Diabetes, Gestational; Pregnancy in Obesity

Interventions

Observation

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Pregnancy in Diabetics; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Birth Weight; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Gene T Lee, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 5, 2023
• Study Start: August 10, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)