Clinical trial NCT06757374: First Trimester Resistin Levels in HG
Official title: Evaluation of First-Trimester Maternal Serum Resistin in Hyperemesis Gravidarum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperemesis Gravidarum - Severe
Resistin
Gestational Diabetes Mellitus (GDM)
Keywords: First trimester
maternal serum resistin
hyperemesis gravidarum
HG
GDM
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-01-03
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: PUQE
timeFrame: Immediately after admission in the first trimester
Secondary outcomes:
measure: Resistin levels
timeFrame: Immediately after admission in the first trimester
measure: OGTT
timeFrame: admission in 24-28 th week in pregnancy
Other outcomes:
Locations:
city: Kartal
country: Turkey
facility: Kartal Dr Lutfi Kirdar City Hospital
state: İstanbul
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.