Hyperemesis GravidarumNCT05446025
The Levels of the Orexin, Galanin and aMSH and CART in Patients With Hyperemesis Gravidarum
An observational study of Hyperemesis Gravidarum and Pregnancy Related, run by Siirt University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Hyperemesis Gravidarum, Pregnancy Related
- What is being tested?
- Blood sample
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2022to 1 Feb 2023
- How long will I take part?
- 7 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women diagnosed with hyperesis gravidarum
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
-
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Hyperemesis Gravidarum, Pregnancy Related
- Being tested
- Blood sample
- Keywords
- vomiting, pregnant, ketonuria
- Medical subject headings
- Hyperemesis Gravidarum, Vomiting, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleDiagnostic test
Orexigenic hormones (appetizing) Orexin, galanin and anorexigenic hormones (decreasing appetite) aMSH and CART blood levels will be measured
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 . Receives: Diagnostic Test: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 20th week of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start26 Jun 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hyperemesis GravidarumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 7 Months
Sponsor and investigators
- Lead sponsor
- Siirt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serif Aksin, Siirt University
- Investigators
- Şerif Aksin, Assoc.Prof, Study director, Siirt University Medical Faculty Obstetrics and Gynecology Departmant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446025
- Sponsor's protocol ID
- SiirtUNIVers
- Status last verified
- Jan 2023
- First submitted
- 26 Jun 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22369786Sohn JW. Network of hypothalamic neurons that control appetite. BMB Rep. 2015 Apr;48(4):229-33. doi: 10.5483/bmbrep.2015.48.4.272.
PubMed 25560696London 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.
PubMed 28641304
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05446025
- Acronym / sponsor ID
- SiirtUNIVers
- Conditions
- Hyperemesis Gravidarum, Pregnancy Related
- Keywords
- vomiting, pregnant, ketonuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Siirt UniversityUniversity, hospital or other
- Study start
- 26 Jun 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnant women with a diagnosis of hyperemesis gravidarum( n:50) | – | Diagnostic Test: Blood sampleOrexigenic hormones (appetizing) Orexin, galanin and anorexigenic hormones (decreasing appetite) aMSH and CART blood levels will be examined in patients with hyperemesis gravidarum. |
| Control group pregnants (n:50) | – | Diagnostic Test: Blood sampleOrexigenic hormones (appetizing) Orexin, galanin and anorexigenic hormones (decreasing appetite) aMSH and CART blood levels will be examined in the patients of the control group . |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women diagnosed with hyperesis gravidarum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleOrexigenic hormones (appetizing) Orexin, galanin and anorexigenic hormones (decreasing appetite) aMSH and CART blood levels will be measured | Diagnostic test | Control group pregnants (n:50), pregnant women with a diagnosis of hyperemesis gravidarum( n:50) |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Background: PubMed 22369786Parker 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.
- Background: PubMed 25560696Sohn JW. Network of hypothalamic neurons that control appetite. BMB Rep. 2015 Apr;48(4):229-33. doi: 10.5483/bmbrep.2015.48.4.272.
- Background: PubMed 28641304London 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şerif Aksin, Assoc.Prof study director
Siirt University Medical Faculty Obstetrics and Gynecology Departmant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperemesis Gravidarum and Pregnancy Related, run by Siirt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of hyperemesis gravidarum and levels of orexigenic and anorexigenic blood hormones (time frame: Up to 20th week of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05446025, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.