First Trimester Resistin Levels in HG

Not Applicable

Completed

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

• Registration Number: NCT06757374
• Lead Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-15
• Primary Completion: 2023-03-15
• Study Completion: 2023-06-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-24
• Study First Submitted QC: 2024-12-24
• Last Update Submitted: 2024-12-24
• Study First Posted: 2025-01-03
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 210

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
PUQE	Immediately after admission in the first trimester	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

Secondary Outcome Measures

Name	Time	Method
Resistin levels	Immediately after admission in the first trimester	Resistin levels rise with HG severity
OGTT	admission in 24-28 th week in pregnancy	After 75 grams of solution was given, blood glucose values were evaluated again at 1st and 2nd hours. GDM was diagnosed when one of the 3 levels of blood sugar was reached or exceeded (Fasting: 92 mg/dl, 1 hour later: 180 mg/dl, 2 hours later: 153 mg/dl).

Trial Locations

Locations (1)

Kartal Dr Lutfi Kirdar City Hospital; 🇹🇷 Kartal, İstanbul, Turkey