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

August 30, 2024 updated by: Fahri Burcin Firatligil, Ankara Etlik City Hospital

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

302

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Yenimahalle
      • Ankara, Yenimahalle, Turkey
        • Ankara Etlik City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
women with macrosomic newborns
association between TyG index and triglyceride to high-density lipoprotein cholesterol ratio with fetal macrosomia
Other Names:
  • Triglyceride to high-density lipoprotein cholesterol ratio
Control group
women with non-macrosomic newborns
association between TyG index and triglyceride to high-density lipoprotein cholesterol ratio with fetal macrosomia
Other Names:
  • Triglyceride to high-density lipoprotein cholesterol ratio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The TyG index
Time Frame: 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.
between 28 and 40 weeks of pregnancy
The triglyceride to high density lipoprotein cholesterol ratio
Time Frame: 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.
between 28 and 40 weeks of pregnancy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HOMA-IR
Time Frame: 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.
between 28 and 40 weeks of pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Yaprak Engin-Ustun, Prof, Etlik Zubeyde Hanim Women's Health Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

July 30, 2024

Study Completion (Actual)

August 25, 2024

Study Registration Dates

First Submitted

June 8, 2024

First Submitted That Met QC Criteria

June 17, 2024

First Posted (Actual)

June 18, 2024

Study Record Updates

Last Update Posted (Actual)

September 3, 2024

Last Update Submitted That Met QC Criteria

August 30, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data are available on request only due to ethical, legal or commercial reasons

IPD Sharing Time Frame

one or two months

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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