Adenoid HypertrophyNCT07887451
Serum and Salivary Leptin Levels in Children With Adenoid/Adenotonsillar Hypertrophy
An observational study of Adenoid Hypertrophy and Adenotonsillar Hypertrophy, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
Adenoid and adenotonsillar hypertrophy are among the most common causes of nasal obstruction, snoring and sleep-disordered breathing in children, and chronic upper airway obstruction may affect growth, appetite and energy metabolism. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adenoid Hypertrophy, Adenotonsillar Hypertrophy
- What is being tested?
- Blood and saliva sampling
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2026to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children aged 3 to 18 years presenting to the Otorhinolaryngology outpatient clinic of Harran University Faculty of Medicine, Şanlıurfa, Turkey, with adenoid or adenotonsillar hypertrophy, and age- and sex-matched children without adenoid or adenotonsillar hypertrophy presenting to the same clinic.
Who may be able to join
- Age 3 to 18 years
- Diagnosis of adenoid hypertrophy or adenoid and palatine tonsil hypertrophy at the Otorhinolaryngology outpatient clinic by clinical examination with or without endoscopic evaluation
- Stable general condition without known chronic systemic disease
- No medical contraindication to venous blood and saliva sampling
- Written informed consent obtained from a parent or legal guardian
- Age 3 to 18 years
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- No adenoid or adenotonsillar hypertrophy on clinical and endoscopic evaluation
- No history of nasal obstruction, chronic snoring or sleep-disordered breathing
- Similar age and sex distribution to the patient group
- No known chronic systemic disease and no medical contraindication to venous blood and saliva sampling
- Written informed consent obtained from a parent or legal guardian
Who cannot join
- Signs of acute upper or lower respiratory tract infection at the time of sampling or within the previous 2 weeks
- Chronic endocrine, metabolic, cardiac, renal, hepatic or hematologic systemic disease
- Obesity, growth retardation or a clinically diagnosed nutritional disorder
- Previous adenoidectomy or adenotonsillectomy
- Use of systemic corticosteroids, hormone preparations or immunomodulatory drugs within the last 3 months
- Insufficient cooperation during clinical evaluation or sampling, or inability to obtain an adequate blood and/or saliva sample
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- Lack of written informed consent from a parent or legal guardian
- Control Group
- Same exclusion criteria as the patient group
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Harran University Faculty of Medicine Hospital, Department of Otorhinolaryngology
Sanliurfa, Şanlıurfa, 63300
Mahmut Ağırtmış, MD, +905012392163, mahmutagirtmis@harran.edu.tr
About this study
Official title: Comparison of Serum and Salivary Leptin Levels in Children With and Without Adenoid/Adenotonsillar Hypertrophy
Adenoid and adenotonsillar hypertrophy are among the most common causes of nasal obstruction, snoring and sleep-disordered breathing in children, and chronic upper airway obstruction may affect growth, appetite and energy metabolism. Leptin is an adipose tissue-derived hormone that regulates appetite and energy balance. This prospective case-control study aims to compare serum and salivary leptin levels between children with adenoid/adenotonsillar hypertrophy and age- and sex-matched children without adenoid/adenotonsillar hypertrophy, to evaluate the relationship of leptin levels with height, weight and body mass index, and to assess whether salivary leptin, a non-invasive measure, reflects serum leptin levels.
Read the detailed description
Children aged 3 to 18 years presenting to the Otorhinolaryngology outpatient clinic of Harran University Faculty of Medicine will be enrolled. The patient group will consist of 40 children diagnosed with adenoid hypertrophy or adenoid and palatine tonsil hypertrophy by clinical examination with or without endoscopic evaluation. The control group will consist of 40 age- and sex-matched children without adenoid or adenotonsillar hypertrophy and without a history of nasal obstruction, chronic snoring or sleep-disordered breathing.
In all participants, a venous blood sample (approximately 5 ml) and an unstimulated saliva sample will be collected in the morning after fasting during routine clinical evaluation. Samples will be centrifuged, and serum and saliva fractions will be stored at -80 °C until analysis. After sample collection is completed, all samples will be thawed and analyzed in the same session, and leptin levels will be measured by enzyme-linked immunosorbent assay (ELISA) using a commercial kit according to the manufacturer's instructions. Height and weight will be measured using standard methods, and body mass index will be calculated.
Serum and salivary leptin levels will be compared between groups using the independent samples t-test or Mann-Whitney U test according to data distribution, and categorical variables will be compared using the chi-square or Fisher's exact test. Correlations between serum and salivary leptin levels and between leptin levels and height, weight and body mass index will be assessed using Pearson or Spearman correlation analysis. Multivariable regression analysis will be performed when necessary. No intervention other than routine clinical care will be applied to participants.
- Conditions
- Adenoid Hypertrophy, Adenotonsillar Hypertrophy
- Being tested
- Blood and saliva sampling
- Keywords
- Leptin, Saliva, Salivary Biomarkers, Body Mass Index, Adipokines, Pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and saliva samplingOther
A fasting morning venous blood sample (approximately 5 ml) and an unstimulated saliva sample are collected during routine clinical evaluation for measurement of leptin levels by ELISA. No additional intervention is applied.
| Study group | Role | What they receive |
|---|---|---|
| Adenoid/Adenotonsillar Hypertrophy Group | Children aged 3 to 18 years diagnosed with adenoid hypertrophy or adenoid and palatine tonsil hypertrophy by clinical examination with or without endoscopic evaluation. A fasting morning venous blood sample and an unstimulated saliva sample are collected, and height and weight are measured. No additional intervention is applied. Receives: Other: Blood and saliva sampling | |
| Control Group | Age- and sex-matched children aged 3 to 18 years without adenoid or adenotonsillar hypertrophy on clinical and endoscopic evaluation, and without a history of nasal obstruction, chronic snoring or sleep-disordered breathing. A fasting morning venous blood sample and an unstimulated saliva sample are collected, and height and weight are measured. No additional intervention is applied. Receives: Other: Blood and saliva sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum leptin level
Serum leptin concentration (ng/mL) measured by ELISA, compared between children with adenoid/adenotonsillar hypertrophy and control subjects.
Measured: At the time of sampling (Day 0)
Salivary leptin level
Unstimulated salivary leptin concentration measured by ELISA, compared between children with adenoid/adenotonsillar hypertrophy and control subjects.
Measured: At the time of sampling (Day 0)
Secondary outcomes (2)
Correlation between serum and salivary leptin levels
Correlation coefficient (Pearson or Spearman) between serum and salivary leptin concentrations, to assess whether salivary leptin reflects serum leptin levels.
Measured: At the time of sampling (Day 0)
Correlation of leptin levels with height, weight and body mass index
Correlation coefficients (Pearson or Spearman) between serum and salivary leptin concentrations and height (cm), weight (kg) and body mass index (kg/m^2).
Measured: At the time of sampling (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start2 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoid HypertrophyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Servet Erdemes, Harran University
- Investigators
- Servet Erdemes, MD, Principal investigator, Harran UniversityMahmut Ağırtmış, MD, Study director, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887451
- Sponsor's protocol ID
- HRÜ/26.02.36
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared in order to protect participant confidentiality in accordance with national personal data protection regulations (KVKK).
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Serum and Salivary Leptin Levels in Children With and Without Adenoid/Adenotonsillar Hypertrophy
- ClinicalTrials.gov ID
- NCT07887451
- Acronym / sponsor ID
- HRÜ/26.02.36
- Conditions
- Adenoid Hypertrophy, Adenotonsillar Hypertrophy
- Keywords
- Leptin, Saliva, Salivary Biomarkers, Body Mass Index, Adipokines, Pediatric
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 21 Oct 2026 (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.
Adenoid and adenotonsillar hypertrophy are among the most common causes of nasal obstruction, snoring and sleep-disordered breathing in children, and chronic upper airway obstruction may affect growth, appetite and energy metabolism. Leptin is an adipose tissue-derived hormone that regulates appetite and energy balance. This prospective case-control study aims to compare serum and salivary leptin levels between children with adenoid/adenotonsillar hypertrophy and age- and sex-matched children without adenoid/adenotonsillar hypertrophy, to evaluate the relationship of leptin levels with height, weight and body mass index, and to assess whether salivary leptin, a non-invasive measure, reflects serum leptin levels.
Detailed description
Children aged 3 to 18 years presenting to the Otorhinolaryngology outpatient clinic of Harran University Faculty of Medicine will be enrolled. The patient group will consist of 40 children diagnosed with adenoid hypertrophy or adenoid and palatine tonsil hypertrophy by clinical examination with or without endoscopic evaluation. The control group will consist of 40 age- and sex-matched children without adenoid or adenotonsillar hypertrophy and without a history of nasal obstruction, chronic snoring or sleep-disordered breathing.
In all participants, a venous blood sample (approximately 5 ml) and an unstimulated saliva sample will be collected in the morning after fasting during routine clinical evaluation. Samples will be centrifuged, and serum and saliva fractions will be stored at -80 °C until analysis. After sample collection is completed, all samples will be thawed and analyzed in the same session, and leptin levels will be measured by enzyme-linked immunosorbent assay (ELISA) using a commercial kit according to the manufacturer's instructions. Height and weight will be measured using standard methods, and body mass index will be calculated.
Serum and salivary leptin levels will be compared between groups using the independent samples t-test or Mann-Whitney U test according to data distribution, and categorical variables will be compared using the chi-square or Fisher's exact test. Correlations between serum and salivary leptin levels and between leptin levels and height, weight and body mass index will be assessed using Pearson or Spearman correlation analysis. Multivariable regression analysis will be performed when necessary. No intervention other than routine clinical care will be applied to participants.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adenoid/Adenotonsillar Hypertrophy Group | – | Other: Blood and saliva samplingChildren aged 3 to 18 years diagnosed with adenoid hypertrophy or adenoid and palatine tonsil hypertrophy by clinical examination with or without endoscopic evaluation. A fasting morning venous blood sample and an unstimulated saliva sample are collected, and height and weight are measured. No additional intervention is applied. |
| Control Group | – | Other: Blood and saliva samplingAge- and sex-matched children aged 3 to 18 years without adenoid or adenotonsillar hypertrophy on clinical and endoscopic evaluation, and without a history of nasal obstruction, chronic snoring or sleep-disordered breathing. A fasting morning venous blood sample and an unstimulated saliva sample are collected, and height and weight are measured. No additional intervention is applied. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children aged 3 to 18 years presenting to the Otorhinolaryngology outpatient clinic of Harran University Faculty of Medicine, Şanlıurfa, Turkey, with adenoid or adenotonsillar hypertrophy, and age- and sex-matched children without adenoid or adenotonsillar hypertrophy presenting to the same clinic.
Key inclusion criteria (11 listed)
- Age 3 to 18 years
- Diagnosis of adenoid hypertrophy or adenoid and palatine tonsil hypertrophy at the Otorhinolaryngology outpatient clinic by clinical examination with or without endoscopic evaluation
- Stable general condition without known chronic systemic disease
- No medical contraindication to venous blood and saliva sampling
- Written informed consent obtained from a parent or legal guardian
Key exclusion criteria (9 listed)
- Signs of acute upper or lower respiratory tract infection at the time of sampling or within the previous 2 weeks
- Chronic endocrine, metabolic, cardiac, renal, hepatic or hematologic systemic disease
- Obesity, growth retardation or a clinically diagnosed nutritional disorder
- Previous adenoidectomy or adenotonsillectomy
- Use of systemic corticosteroids, hormone preparations or immunomodulatory drugs within the last 3 months
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 and saliva samplingA fasting morning venous blood sample (approximately 5 ml) and an unstimulated saliva sample are collected during routine clinical evaluation for measurement of leptin levels by ELISA. No additional intervention is applied. | Other | Adenoid/Adenotonsillar Hypertrophy Group, Control Group |
Primary outcome
Serum leptin level
Time frame: At the time of sampling (Day 0)
Serum leptin concentration (ng/mL) measured by ELISA, compared between children with adenoid/adenotonsillar hypertrophy and control subjects.
Salivary leptin level
Time frame: At the time of sampling (Day 0)
Unstimulated salivary leptin concentration measured by ELISA, compared between children with adenoid/adenotonsillar hypertrophy and control subjects.
2 secondary outcomes
Correlation between serum and salivary leptin levels
Time frame: At the time of sampling (Day 0)
Correlation of leptin levels with height, weight and body mass index
Time frame: At the time of sampling (Day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared in order to protect participant confidentiality in accordance with national personal data protection regulations (KVKK).
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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.
Servet Erdemes, MD principal investigator
Harran University
Mahmut Ağırtmış, MD study director
Harran University
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 Adenoid Hypertrophy and Adenotonsillar Hypertrophy, run by Harran 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?
The sponsor lists 11 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmut Ağırtmış, MD (+905012392163, mahmutagirtmis@harran.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum leptin level (time frame: At the time of sampling (Day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2026.