First Trimester Resistin Levels in HG

December 24, 2024 updated by: Mehmet Mete Kırlangıç, Dr. Lutfi Kirdar Kartal Training and Research Hospital

Evaluation of First-Trimester Maternal Serum Resistin in Hyperemesis Gravidarum

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • İstanbul
      • Kartal, İstanbul, Turkey, 34758
        • Kartal Dr Lutfi Kirdar City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Diagnostic test: Resistin
Considering the HG effect on endocrinologic and metabolic complications, resistin levels in maternal serum may change in the presence of HG severity
Other Names:
  • Adipose tissue-specific secretory factor
Experimental: 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
Diagnostic test: Resistin
Considering the HG effect on endocrinologic and metabolic complications, resistin levels in maternal serum may change in the presence of HG severity
Other Names:
  • Adipose tissue-specific secretory factor
Experimental: 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.
Diagnostic test: Resistin
Considering the HG effect on endocrinologic and metabolic complications, resistin levels in maternal serum may change in the presence of HG severity
Other Names:
  • Adipose tissue-specific secretory factor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PUQE
Time Frame: 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
Immediately after admission in the first trimester

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resistin levels
Time Frame: Immediately after admission in the first trimester
Resistin levels rise with HG severity
Immediately after admission in the first trimester
OGTT
Time Frame: 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).
admission in 24-28 th week in pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Actual)

March 15, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

December 24, 2024

First Submitted That Met QC Criteria

December 24, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 24, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2020.1141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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