First Trimester Resistin Levels in HG

NCT ID: NCT06757374

Last Updated: 2025-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-15

Study Completion Date

2023-06-01

Brief Summary

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This cross-sectional case-control study was conducted in Tuzla State Hospital Obstetrics Clinic in Turkey. The study evaluated 400 pregnant women during their first trimester of pregnancy. Many pregnant women (50-90%) experience nausea and vomiting during their first trimester; however, some patients have a disease called "hyperemesis gravidarum" (HG) characterized by very severe nausea and vomiting that may require hospitalization. resistin" is a peptide which is secreted primarily by human adipocytes and mononuclear cells. Evidence suggests that resistin increases plasma glucose concentration, reduces glucose intake by adipocytes, and promotes insulin resistance. Considering the HG effect on endocrinologic and metabolic complications, we hypothesized that resistin levels in maternal serum may change in the presence of HG; therefore, the aim of the present study was to evaluate these resistin levels during the first trimester and their correlation with HG severity.

Detailed Description

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Conditions

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Hyperemesis Gravidarum - Severe Resistin Gestational Diabetes Mellitus (GDM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Mild HG

In pregnant women admitted in the first trimester, blood samples were first taken and the PUQE-24 questionnaire was used to evaluate the severity of HG, and those with a score of ≤6 were considered as mild HG

Group Type EXPERIMENTAL

Resistin

Intervention Type DIAGNOSTIC_TEST

Considering the HG effect on endocrinologic and metabolic complications, resistin levels in maternal serum may change in the presence of HG severity

Modarete HG

In pregnant women admitted in the first trimester, blood samples were first taken and the PUQE-24 questionnaire was used to evaluate the severity of HG, and those with a score of 7-12 were considered as modarete HG

Group Type EXPERIMENTAL

Resistin

Intervention Type DIAGNOSTIC_TEST

Considering the HG effect on endocrinologic and metabolic complications, resistin levels in maternal serum may change in the presence of HG severity

Severe HG

In pregnant women admitted in the first trimester, blood samples were first taken and the PUQE-24 questionnaire was used to assess the severity of HG, and those with a score of ≥13 were considered to have severe HG.

Group Type EXPERIMENTAL

Resistin

Intervention Type DIAGNOSTIC_TEST

Considering the HG effect on endocrinologic and metabolic complications, resistin levels in maternal serum may change in the presence of HG severity

Interventions

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Resistin

Considering the HG effect on endocrinologic and metabolic complications, resistin levels in maternal serum may change in the presence of HG severity

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Adipose tissue-specific secretory factor

Eligibility Criteria

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Inclusion Criteria

Those who applied in the first trimester and had a mid-trimester OGTT result

Exclusion Criteria

1\) multifetal pregnancy, 2) fetal chromosomal or structural anomalies, 3) pregestational DM, 4) chronic hypertension or history of preeclampsia, 5) thyroid disease, 5) chronic kidney disease, 6) autoimmune disease, or 7) long-term use of aspirin or glucocorticoids 8) without OGTT results.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Lutfi Kirdar Kartal Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mehmet Mete Kırlangıç

Assoc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kartal Dr Lutfi Kirdar City Hospital

Kartal, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Siddiqui K, George TP. Resistin role in development of gestational diabetes mellitus. Biomark Med. 2017 Jul;11(7):579-586. doi: 10.2217/bmm-2017-0013. Epub 2017 Jul 7.

Reference Type BACKGROUND
PMID: 28685604 (View on PubMed)

Vitoratos N, Deliveliotou A, Dimitrakaki A, Hassiakos D, Panoulis C, Deligeoroglou E, Creatsas GK. Maternal serum resistin concentrations in gestational diabetes mellitus and normal pregnancies. J Obstet Gynaecol Res. 2011 Feb;37(2):112-8. doi: 10.1111/j.1447-0756.2010.01327.x. Epub 2010 Dec 16.

Reference Type BACKGROUND
PMID: 21159034 (View on PubMed)

Nanda S, Poon LC, Muhaisen M, Acosta IC, Nicolaides KH. Maternal serum resistin at 11 to 13 weeks' gestation in normal and pathological pregnancies. Metabolism. 2012 May;61(5):699-705. doi: 10.1016/j.metabol.2011.10.006. Epub 2011 Dec 5.

Reference Type BACKGROUND
PMID: 22146093 (View on PubMed)

Other Identifiers

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09.2020.1141

Identifier Type: -

Identifier Source: org_study_id

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