Influence of TyG Index and TG/HDL-C Ratio on Fetal Macrosomia

Active, not recruiting

• Conditions: Fetal Macrosomatia; Hyperlipidemias; Lipid Metabolism Disorders
• Interventions: Other: TyG index

• Registration Number: NCT06463990
• Lead Sponsor: Ankara Etlik City Hospital

Brief Summary

Metabolic disorders that can occur during pregnancy, in particular disorders of lipid metabolism and insulin resistance, can have a detrimental effect on pregnancy and the fetus.

The triglyceride level and other lipids increase slightly during pregnancy. This increase has a positive effect on the development of the fetus. However, an excessive increase in lipid levels can cause some metabolic disorders such as gestational diabetes and increase feto-maternal morbidity/mortality.

While some existing studies have shown that elevated triglyceride levels can cause fetal macrosomia, others have found no correlation between these two variables. The ratio of triglycerides to HDL is a widely used marker for lipid disorders. In addition, the triglyceride-glucose index is also an index used to detect insulin resistance.

Detailed Description

In this study, the investigators aimed to investigate whether the ratio of triglycerides to high-density lipoprotein cholesterol and the triglyceride glucose index are associated with fetal macrosomia in low-risk nulliparous pregnant women.

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2024-06-08
• Study First Submitted QC: 2024-06-17
• Study First Posted: 2024-06-18
• Primary Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 302

Inclusion Criteria

• Screening for fetal macrosomia was based on the term defined according to the standards of the American College of Obstetricians and Gynecologists (ACOG).
• Low-risk nulliparous singleton pregnant women.
• Age between 18 and 40 years old

Exclusion Criteria

• Post-term pregnancies
• Hospitalized for preterm labor or preterm premature rupture of membranes.
• Gestational diabetes mellitus, diabetes mellitus type I - type II.
• Pregnant women with fetal growth restriction, hypertensive pregnancy disorders, familial hypercholesterolemia and hyperlipidemia.
• Multiparous pregnant women
• Multiple pregnancies
• Pregnant women with chronic diseases.
• Pregnant women with impaired liver function;
• Pregnant women with body mass index <25 and >40 kg/m2.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	TyG index	women with macrosomic newborns
Control group	TyG index	women with non-macrosomic newborns

Primary Outcome Measures

Name	Time	Method
The triglyceride to high density lipoprotein cholesterol ratio	between 28 and 40 weeks of pregnancy	The triglyceride to high density lipoprotein cholesterol ratio was calculated from the blood samples taken from pregnant women in the third trimester.
The TyG index	between 28 and 40 weeks of pregnancy	The triglyceride-glucose index was determined using the formula Ln \[fasting triglycerides (mg/dL) × fasting plasma glucose (mg (dL)/2\], with blood samples taken from pregnant women in the third trimester.

Secondary Outcome Measures

Name	Time	Method
HOMA-IR	between 28 and 40 weeks of pregnancy	HOMA-IR was calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5 with blood samples taken from pregnant women in the third trimester.

Trial Locations

Locations (1)

Ankara Etlik City Hospital; 🇹🇷 Ankara, Yenimahalle, Turkey