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

Hyperlipidemias Clinical Trial

Official title:

Association Between the Triglyceride-glucose Index and the Ratio of Triglyceride to High-density Lipoprotein Cholesterol With Fetal Macrosomia in Low-risk Nulliparous Pregnant Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06463990
• Other study ID #: AECH-FIRATLIGIL-001
• Status: Active, not recruiting
• Start date: January 1, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: June 2024
• Source: Ankara Etlik City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 302
• Est. completion date: July 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fetal Macrosomia
• Hyperlipidemias
• Lipid Metabolism Disorders
• Metabolic Diseases

Intervention

Other:
• TyG index
association between TyG index and triglyceride to high-density lipoprotein cholesterol ratio with fetal macrosomia

Locations

Country	Name	City	State
Turkey	Ankara Etlik City Hospital	Ankara	Yenimahalle

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Etlik City Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Babic N, Valjevac A, Zaciragic A, Avdagic N, Zukic S, Hasic S. The Triglyceride/HDL Ratio and Triglyceride Glucose Index as Predictors of Glycemic Control in Patients with Diabetes Mellitus Type 2. Med Arch. 2019 Jun;73(3):163-168. doi: 10.5455/medarh.201 — View Citation

Barat S, Ghanbarpour A, Bouzari Z, Batebi Z. Triglyceride to HDL cholesterol ratio and risk for gestational diabetes and birth of a large-for-gestational-age newborn. Caspian J Intern Med. 2018 Fall;9(4):368-375. doi: 10.22088/cjim.9.4.368. — View Citation

Macrosomia: ACOG Practice Bulletin, Number 216. Obstet Gynecol. 2020 Jan;135(1):e18-e35. doi: 10.1097/AOG.0000000000003606. — View Citation

Poveda NE, Garces MF, Darghan AE, Jaimes SAB, Sanchez EP, Diaz-Cruz LA, Garzon-Olivares CD, Parra-Pineda MO, Bautista-Charry AA, Muller EA, Alzate HFS, Acosta LMM, Sanchez E, Ruiz-Parra AI, Caminos JE. Triglycerides/Glucose and Triglyceride/High-Density L — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The TyG index	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.	between 28 and 40 weeks of pregnancy
Primary	The triglyceride to high density lipoprotein cholesterol ratio	The triglyceride to high density lipoprotein cholesterol ratio was calculated from the blood samples taken from pregnant women in the third trimester.	between 28 and 40 weeks of pregnancy
Secondary	HOMA-IR	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.	between 28 and 40 weeks of pregnancy