- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06463990
Influence of TyG Index and TG/HDL-C Ratio on Fetal Macrosomia
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
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Yenimahalle
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Ankara, Yenimahalle, Turkey
- Ankara Etlik City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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:
|
|
Control group
women with non-macrosomic newborns
|
association between TyG index and triglyceride to high-density lipoprotein cholesterol ratio with fetal macrosomia
Other Names:
|
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
Sponsor
Investigators
- Study Director: Yaprak Engin-Ustun, Prof, Etlik Zubeyde Hanim Women's Health Education and Research Hospital
Publications and helpful links
General Publications
- Macrosomia: ACOG Practice Bulletin, Number 216. Obstet Gynecol. 2020 Jan;135(1):e18-e35. doi: 10.1097/AOG.0000000000003606.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Body Weight
- Fetal Diseases
- Pregnancy Complications
- Dyslipidemias
- Diabetes, Gestational
- Pregnancy in Diabetics
- Birth Weight
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Hyperlipidemias
- Metabolic Diseases
- Lipid Metabolism Disorders
- Fetal Macrosomia
Other Study ID Numbers
- AECH-FIRATLIGIL-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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