First Trimester Resistin Levels in HG

NCT06757374 | Completed

• 1 other identifier: 09.2020.1141
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperemesis Gravidarum - Severe; Resistin; Gestational Diabetes Mellitus (GDM)

Keywords

First trimester; maternal serum resistin; hyperemesis gravidarum; HG; GDM

Outcome Measures

Primary Outcomes (1)

• PUQE

  the PUQE-24 questionnaire was used to evaluate the severity of HG, and those with a score of ≤6 were considered as mild HG, 6-12 as moderate HG, and ≥13 as severe HG

  Immediately after admission in the first trimester

Secondary Outcomes (2)

• Resistin levels

  Immediately after admission in the first trimester

• OGTT

  admission in 24-28 th week in pregnancy

Study Arms (3)

Mild HG

EXPERIMENTAL

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

Diagnostic Test: Resistin

Modarete HG

EXPERIMENTAL

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

Diagnostic Test: Resistin

Severe HG

EXPERIMENTAL

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.

Diagnostic Test: Resistin

Interventions

Resistin DIAGNOSTIC_TEST

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

Also known as: Adipose tissue-specific secretory factor

Mild HG; Modarete HG; Severe HG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

Kartal Dr Lutfi Kirdar City Hospital

Kartal, Istanbul, 34758, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 28685604 BACKGROUND

• 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.

  PMID: 21159034 BACKGROUND

• 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.

  PMID: 22146093 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational; Hyperemesis Gravidarum

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Morning Sickness; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 3, 2025
• Study Start: December 15, 2022
• Primary Completion: March 15, 2023
• Study Completion: June 1, 2023
• Last Updated: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)