An observational study in Adenoid Hypertrophy and Adenotonsillar Hypertrophy, sponsored by Harran University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 3 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Harran University · Observational
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.
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.
Harran University is the lead sponsor of 62 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Adenoid/Adenotonsillar Hypertrophy Group
Inclusion Criteria:
Exclusion Criteria:
Control Group
Inclusion Criteria:
Exclusion Criteria:
* Same exclusion criteria as the patient 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.
Other: Blood and saliva sampling
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.
Other: Blood and saliva sampling
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.
Serum leptin level
Serum leptin concentration (ng/mL) measured by ELISA, compared between children with adenoid/adenotonsillar hypertrophy and control subjects.
Time frame: 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.
Time frame: At the time of sampling (Day 0)
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.
Time frame: 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).
Time frame: At the time of sampling (Day 0)
Plan to share: No — Individual participant data will not be shared in order to protect participant confidentiality in accordance with national personal data protection regulations (KVKK).
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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