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

NCT05446025 | Completed

• 1 other identifier: SiirtUNIVers
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperemesis Gravidarum; Pregnancy Related

Keywords

vomiting; pregnant; ketonuria

Outcome Measures

Primary Outcomes (1)

• Comparison of hyperemesis gravidarum and levels of orexigenic and anorexigenic blood hormones

  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

Study Arms (2)

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

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

Interventions

Blood sample DIAGNOSTIC_TEST

Orexigenic hormones (appetizing) Orexin, galanin and anorexigenic hormones (decreasing appetite) aMSH and CART blood levels will be measured

Control group pregnants (n:50); pregnant women with a diagnosis of hyperemesis gravidarum( n:50)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women diagnosed with hyperesis gravidarum

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siirt University: lead

Study Sites (1)

Siirt Üniversity Medical Faculty

Siirt, 56000, Turkey (Türkiye)

Location

Related Publications (3)

• Parker JA, Bloom SR. Hypothalamic neuropeptides and the regulation of appetite. Neuropharmacology. 2012 Jul;63(1):18-30. doi: 10.1016/j.neuropharm.2012.02.004. Epub 2012 Feb 19.

  PMID: 22369786 BACKGROUND

• Sohn JW. Network of hypothalamic neurons that control appetite. BMB Rep. 2015 Apr;48(4):229-33. doi: 10.5483/bmbrep.2015.48.4.272.

  PMID: 25560696 BACKGROUND

• London V, Grube S, Sherer DM, Abulafia O. Hyperemesis Gravidarum: A Review of Recent Literature. Pharmacology. 2017;100(3-4):161-171. doi: 10.1159/000477853. Epub 2017 Jun 23.

  PMID: 28641304 BACKGROUND

MeSH Terms

Conditions

Hyperemesis Gravidarum; Vomiting; Ketosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Morning Sickness; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Şerif Aksin, Assoc.Prof

  Siirt University Medical Faculty Obstetrics and Gynecology Departmant

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 26, 2022
• First Posted: July 6, 2022
• Study Start: June 26, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 2, 2023

Record last verified: 2023-01

Locations

TU (1)