Hyperemesis Gravidarum - SevereNCT06757374
First Trimester Resistin Levels in HG
A study testing Resistin in people with Hyperemesis Gravidarum - Severe and Resistin, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperemesis Gravidarum - Severe, Resistin, Gestational Diabetes Mellitus (GDM)
- What is being tested?
- Resistin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2022to 1 Jun 2023
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those who applied in the first trimester and had a mid-trimester OGTT result
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr Lutfi Kirdar City Hospital
Kartal, Istanbul, 34758
About this study
Official title: 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.
- Being tested
- Resistin
- Keywords
- First trimester, maternal serum resistin, hyperemesis gravidarum, HG, GDM
- Medical subject headings
- Diabetes, Gestational, Hyperemesis Gravidarum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResistinDiagnostic test
Also called Adipose tissue-specific secretory factor
Considering the HG effect on endocrinologic and metabolic complications, resistin levels in maternal serum may change in the presence of HG severity
| Study group | Role | What they receive |
|---|---|---|
| Mild HG | Experimental | 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 Receives: Diagnostic Test: Resistin |
| Modarete HG | Experimental | 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 Receives: Diagnostic Test: Resistin |
| Severe HG | Experimental | 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. Receives: Diagnostic Test: Resistin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PUQE
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
Measured: Immediately after admission in the first trimester
Secondary outcomes (2)
Resistin levels
Resistin levels rise with HG severity
Measured: Immediately after admission in the first trimester
OGTT
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).
Measured: admission in 24-28 th week in pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start15 Dec 2022
- Primary completion15 Mar 2023
- Study completion1 Jun 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 Gravidarum - SevereStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Mete Kırlangıç, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757374
- Sponsor's protocol ID
- 09.2020.1141
- Status last verified
- Dec 2024
- First submitted
- 24 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siddiqui K, George TP. Resistin role in development of gestational diabetes mellitus. Biomark Med. 2017 Jul;11(7):579-586. doi: 10.2217/bmm-2017-0013. Epub 2017 Jul 7.
PubMed 28685604Vitoratos N, Deliveliotou A, Dimitrakaki A, Hassiakos D, Panoulis C, Deligeoroglou E, Creatsas GK. Maternal serum resistin concentrations in gestational diabetes mellitus and normal pregnancies. J Obstet Gynaecol Res. 2011 Feb;37(2):112-8. doi: 10.1111/j.1447-0756.2010.01327.x. Epub 2010 Dec 16.
PubMed 21159034Nanda S, Poon LC, Muhaisen M, Acosta IC, Nicolaides KH. Maternal serum resistin at 11 to 13 weeks' gestation in normal and pathological pregnancies. Metabolism. 2012 May;61(5):699-705. doi: 10.1016/j.metabol.2011.10.006. Epub 2011 Dec 5.
PubMed 22146093
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of First-Trimester Maternal Serum Resistin in Hyperemesis Gravidarum
- ClinicalTrials.gov ID
- NCT06757374
- Acronym / sponsor ID
- 09.2020.1141
- Keywords
- First trimester, maternal serum resistin, hyperemesis gravidarum, HG, GDM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 3 Jan 2025 (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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild HG | Experimental | Diagnostic Test: ResistinIn 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 |
| Modarete HG | Experimental | Diagnostic Test: ResistinIn 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 |
| Severe HG | Experimental | Diagnostic Test: ResistinIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Those who applied in the first trimester and had a mid-trimester OGTT result
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| ResistinAlso: Adipose tissue-specific secretory factorConsidering the HG effect on endocrinologic and metabolic complications, resistin levels in maternal serum may change in the presence of HG severity | Diagnostic test | Mild HG, Modarete HG, Severe HG |
Primary outcome
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
2 secondary outcomes
Resistin levels
Time frame: Immediately after admission in the first trimester
OGTT
Time frame: admission in 24-28 th week in pregnancy
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 3 Jan 2025.
- Background: PubMed 28685604Siddiqui K, George TP. Resistin role in development of gestational diabetes mellitus. Biomark Med. 2017 Jul;11(7):579-586. doi: 10.2217/bmm-2017-0013. Epub 2017 Jul 7.
- Background: PubMed 21159034Vitoratos N, Deliveliotou A, Dimitrakaki A, Hassiakos D, Panoulis C, Deligeoroglou E, Creatsas GK. Maternal serum resistin concentrations in gestational diabetes mellitus and normal pregnancies. J Obstet Gynaecol Res. 2011 Feb;37(2):112-8. doi: 10.1111/j.1447-0756.2010.01327.x. Epub 2010 Dec 16.
- Background: PubMed 22146093Nanda S, Poon LC, Muhaisen M, Acosta IC, Nicolaides KH. Maternal serum resistin at 11 to 13 weeks' gestation in normal and pathological pregnancies. Metabolism. 2012 May;61(5):699-705. doi: 10.1016/j.metabol.2011.10.006. Epub 2011 Dec 5.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistin in people with Hyperemesis Gravidarum - Severe and Resistin, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 3 Jan 2025. 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?
PUQE (time frame: Immediately after admission in the first trimester). 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 NCT06757374, 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 3 Jan 2025.