Fetal MacrosomatiaNCT06463990
Influence of TyG Index and TG/HDL-C Ratio on Fetal Macrosomia
An observational study of Fetal Macrosomatia and Lipid Metabolism Disorders, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Macrosomatia, Lipid Metabolism Disorders, Hyperlipidemias
- What is being tested?
- TyG index
- How many people
- 302 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 25 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnant women with chronic diseases.
- Pregnant women with impaired liver function;
- Pregnant women with body mass index <25 and >40 kg/m2.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Yenimahalle
About this study
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
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.
Read the 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.
- Being tested
- TyG index
- Keywords
- Fetal macrosomia, Nulliparous, Triglyceride, TyG index
- Medical subject headings
- Lipid Metabolism Disorders, Hyperlipidemias, Fetal Macrosomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TyG indexOther
Also called Triglyceride to high-density lipoprotein cholesterol ratio
association between TyG index and triglyceride to high-density lipoprotein cholesterol ratio with fetal macrosomia
| Study group | Role | What they receive |
|---|---|---|
| Study group | women with macrosomic newborns Receives: Other: TyG index | |
| Control group | women with non-macrosomic newborns Receives: Other: TyG index |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: between 28 and 40 weeks of pregnancy
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.
Measured: between 28 and 40 weeks of pregnancy
Secondary outcomes (1)
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.
Measured: between 28 and 40 weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 Jan 2023
- Primary completion30 Jul 2024
- Study completion25 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Fetal MacrosomatiaStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fahri Burcin Firatligil, Ankara Etlik City Hospital
- Investigators
- Yaprak Engin-Ustun, Prof, Study director, Etlik Zubeyde Hanim Women's Health Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463990
- Sponsor's protocol ID
- AECH-FIRATLIGIL-001
- Status last verified
- Aug 2024
- First submitted
- 8 Jun 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available on request only due to ethical, legal or commercial reasons
Publications
Macrosomia: ACOG Practice Bulletin, Number 216. Obstet Gynecol. 2020 Jan;135(1):e18-e35. doi: 10.1097/AOG.0000000000003606.
PubMed 31856124Poveda 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.
PubMed 30158976Babic 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.
PubMed 31404127Barat 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.
PubMed 30510652Firatligil FB, Tuncdemir S, Sucu S, Reis YA, Ozkan S, Dereli ML, Sucu ST, Engin-Ustun Y. Association of the triglyceride-glucose index and the ratio of triglyceride to high-density lipoprotein cholesterol with fetal macrosomia in nulliparous pregnant women: a prospective case-control study. BMC Pregnancy Childbirth. 2025 Feb 17;25(1):175. doi: 10.1186/s12884-025-07317-5.
PubMed 39962459
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06463990
- Acronym / sponsor ID
- AECH-FIRATLIGIL-001
- Keywords
- Fetal macrosomia, Nulliparous, Triglyceride, TyG index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 25 Aug 2024 (actual)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: TyG indexwomen with macrosomic newborns |
| Control group | – | Other: TyG indexwomen with non-macrosomic newborns |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TyG indexAlso: Triglyceride to high-density lipoprotein cholesterol ratioassociation between TyG index and triglyceride to high-density lipoprotein cholesterol ratio with fetal macrosomia | Other | Control group, Study group |
Primary outcome
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.
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.
1 secondary outcome
HOMA-IR
Time frame: between 28 and 40 weeks of pregnancy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Results publication: PubMed 31856124Macrosomia: ACOG Practice Bulletin, Number 216. Obstet Gynecol. 2020 Jan;135(1):e18-e35. doi: 10.1097/AOG.0000000000003606.
- Results publication: PubMed 30158976Poveda 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.
- Results publication: PubMed 31404127Babic 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.
- Results publication: PubMed 30510652Barat 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.
- Derived from this study: PubMed 39962459Firatligil FB, Tuncdemir S, Sucu S, Reis YA, Ozkan S, Dereli ML, Sucu ST, Engin-Ustun Y. Association of the triglyceride-glucose index and the ratio of triglyceride to high-density lipoprotein cholesterol with fetal macrosomia in nulliparous pregnant women: a prospective case-control study. BMC Pregnancy Childbirth. 2025 Feb 17;25(1):175. doi: 10.1186/s12884-025-07317-5.
- Individual participant dataSharing planned: Yes. Data are available on request only due to ethical, legal or commercial reasons
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaprak Engin-Ustun, Prof study director
Etlik Zubeyde Hanim Women's Health Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Macrosomatia and Lipid Metabolism Disorders, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The TyG index (time frame: between 28 and 40 weeks of pregnancy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06463990, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.