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

Sponsor
Siirt University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05446025
Collaborator
(none)
100
1
4.1
24.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Blood sample

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
MSH and CART Levels of Orexigenic Hormones (Which Increase Appetite), Orexin, Galanin and Anorexigenic Hormones (Which Reduce Appetite) in Patients With Hyperemesis Gravidarum
Actual Study Start Date :
Jun 26, 2022
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Comparison of hyperemesis gravidarum and levels of orexigenic and anorexigenic blood hormones [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No

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

-

Contacts and Locations

Locations

Site City State Country Postal Code
1 Siirt Üniversity Medical Faculty Siirt Turkey 56000

Sponsors and Collaborators

  • Siirt University

Investigators

  • Study Director: Şerif Aksin, Assoc.Prof, Siirt University Medical Faculty Obstetrics and Gynecology Departmant

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Serif Aksin, Associate professor, Siirt University
ClinicalTrials.gov Identifier:
NCT05446025
Other Study ID Numbers:
  • SiirtUNIVers
First Posted:
Jul 6, 2022
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Serif Aksin, Associate professor, Siirt University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2022