The Levels of the Orexin, Galanin and aMSH and CART in Patients With Hyperemesis Gravidarum

December 5, 2022 updated by: Serif Aksin, Siirt University

MSH and CART Levels of Orexigenic Hormones (Which Increase Appetite), Orexin, Galanin and Anorexigenic Hormones (Which Reduce Appetite) in Patients With Hyperemesis Gravidarum

Hyperemesis gravidarum is a disease of unknown etiology that is frequently encountered in pregnant women and seriously impairs their quality of life. In the United States, hyperemesis gravidarum is the most common cause of hospitalizations in the first half of pregnancy and is second only to preterm labor for hospitalizations during pregnancy overall. The prevalence of hyperemesis gravidarum is approximately 0.3-3% of pregnancies and varies due to different diagnostic criteria and ethnic differences in study populations. According to the latest guidelines from the American College of Obstetricians and Gynecologists (ACOG) on nausea and vomiting during pregnancy, there is still no single accepted definition for hyperemesis gravidarum. The most commonly cited criteria for the diagnosis of hyperemesis gravidarum include persistent, unrelated to other causes, ketonuria, electrolyte abnormalities and acid-base disturbances, as well as weight loss. Weight loss is usually stated as at least 5% loss. In normal individuals, the appetite regulation center is the hypothalamus. Neuropeptides released from hypothalamic neurons play an important role in the regulation of nutrition by acting both in the hypothalamus and other appetite-regulating centers in the brain. Among the neuropeptides that are secreted by the central nervous system and peripheral organs and also play an important role in the regulation of energy and appetite, there are neuropeptides known as orexigenic neuropeptides, which reduce energy expenditure and increase appetite, as well as anorexigenic neuropeptides, which, on the contrary, reduce appetite and increase energy expenditure. It is known that disorders in these pathways cause pathologies in appetite and food intake in normal individuals. In our study, we plan to examine the levels of some neuropeptides in patients with hyperemesis gravidarum in order to investigate whether these pathways are affected or not. In this study, we aimed to investigate whether orexigenic neuropeptides (Orexin, Galanin) and anorexigenic neuropeptides (aMSH, CART) levels are associated with hyperemesis gravidarum.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Our aim in this study is to determine the levels of orexigenic and anorexigenic neuropeptides in patients with hyperemesis gravidarum and to determine whether there is a relationship between the function of the appetite center and the levels of these neuropeptides. For this purpose, approximately 50 pregnant women who were followed up with the diagnosis of hyperemesis gravidarum in Siirt Training and Research Hospital between 26 June 2022 and 30 october 2022 will be included in the study. The pregnant woman's age, pregnancy history, medical history will be recorded. Thyroid function test results, hemogram results and electrolyte levels of all patients will be recorded. Whole blood will be taken from these patients and the levels of Orexin and Galanin, which are orexigenic hormones, and aMSH and CART, which are anorexigenic hormones, will be checked. In the light of the information thus obtained, we plan to determine whether there is a relationship between hyperemesis gravidarum and the appetite center and between orexigenic and anorexigenic hormone levels.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Contact

Study Locations

  • Turkey
      • Siirt, Turkey, 56000
        • Recruiting
        • Siirt Üniversity Medical Faculty

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women diagnosed with hyperesis gravidarum

Description

1-Inclusion Criteria:

5 to 20 weeks of pregnancy

Pregnants with a diagnosis of hyperemesis gravidarum

Pregnants who vomit more than 3 times a day

Those with 5 %more weight loss during pregnancy

detection of ketonuria

2-Exclusion Criteria:

food poisoning

Precision intestinal syndrome

Crohn's disease

Excessive alcohol consumption

Eating disorders such as anorexia and blomia

Neurological conditions such as meningitis, brain tumor and brain trauma

Migraine

Appendicitis

Chemotherapy drugs

Stomach and intestinal infections

Disorders such as celiac or lactose intolerance

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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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pregnant women with a diagnosis of hyperemesis gravidarum( n:50)
Orexigenic hormones (appetizing) Orexin, galanin and anorexigenic hormones (decreasing appetite) aMSH and CART blood levels will be examined in patients with hyperemesis gravidarum.
Diagnostic test: Blood sample
Orexigenic hormones (appetizing) Orexin, galanin and anorexigenic hormones (decreasing appetite) aMSH and CART blood levels will be measured
Control group pregnants (n:50)
Orexigenic hormones (appetizing) Orexin, galanin and anorexigenic hormones (decreasing appetite) aMSH and CART blood levels will be examined in the patients of the control group .
Diagnostic test: Blood sample
Orexigenic hormones (appetizing) Orexin, galanin and anorexigenic hormones (decreasing appetite) aMSH and CART blood levels will be measured

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of hyperemesis gravidarum and levels of orexigenic and anorexigenic blood hormones
Time Frame: Up to 20th week of gestation
Orexigenic hormones (appetizing) Orexin, galanin and anorexigenic hormones (decreasing appetite) aMSH and CART blood levels will be examined in patients with hyperemesis gravidarum.(Blood hormones values will be measured by Elisa method(pg/mL)
Up to 20th week of gestation

Collaborators and Investigators

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

Sponsor

Siirt University

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)

June 26, 2022

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

June 26, 2022

First Submitted That Met QC Criteria

June 30, 2022

First Posted (Actual)

July 6, 2022

Study Record Updates

Last Update Posted (Estimate)

December 6, 2022

Last Update Submitted That Met QC Criteria

December 5, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SiirtUNIVers

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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