Clinical trial NCT06463990: Influence of TyG Index and TG/HDL-C Ratio on Fetal Macrosomia
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Macrosomatia
Lipid Metabolism Disorders
Hyperlipidemias
Keywords: Fetal macrosomia
Nulliparous
Triglyceride
TyG index
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-18
Enrollment: 302
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The singleton pregnant women who delivered a macrosomic newborn were included in the study group (Group I) and the singleton pregnant women who delivered a non-macrosomic fetus were included in the control group (Group II). For each pregnant woman who met the inclusion and exclusion criteria and was eligible for Group I, the first patient in the ranking order of the files who met the criteria previously mentioned in the Materials and Methods section was selected for Group II.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The TyG index
timeFrame: between 28 and 40 weeks of pregnancy
measure: The triglyceride to high density lipoprotein cholesterol ratio
timeFrame: between 28 and 40 weeks of pregnancy
Secondary outcomes:
measure: HOMA-IR
timeFrame: between 28 and 40 weeks of pregnancy
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
state: Yenimahalle
Study officials:
affiliation: Etlik Zubeyde Hanim Women's Health Education and Research Hospital
name: Yaprak Engin-Ustun, Prof
role: STUDY_DIRECTOR
References:
citation: Macrosomia: ACOG Practice Bulletin, Number 216. Obstet Gynecol. 2020 Jan;135(1):e18-e35. doi: 10.1097/AOG.0000000000003606.
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 Lipoprotein Cholesterol Indices in Normal and Preeclamptic Pregnancies: A Longitudinal Study. Int J Endocrinol. 2018 Aug 6;2018:8956404. doi: 10.1155/2018/8956404. eCollection 2018.
citation: 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.2019.73.163-168.
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.