Serum and Salivary Leptin Levels in Children With Adenoid/Adenotonsillar Hypertrophy

NCT07887451 | Recruiting

• 1 other identifier: HRÜ/26.02.36
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Adenoid Hypertrophy; Adenotonsillar Hypertrophy

Keywords

Leptin; Saliva; Salivary Biomarkers; Body Mass Index; Adipokines; Pediatric

Outcome Measures

Primary Outcomes (2)

• Serum leptin level

  Serum leptin concentration (ng/mL) measured by ELISA, compared between children with adenoid/adenotonsillar hypertrophy and control subjects.

  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.

  At the time of sampling (Day 0)

Secondary Outcomes (2)

• Correlation between serum and salivary leptin levels

  At the time of sampling (Day 0)

• Correlation of leptin levels with height, weight and body mass index

  At the time of sampling (Day 0)

Study Arms (2)

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.

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.

Other: Blood and saliva sampling

Interventions

Blood and saliva sampling OTHER

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.

Adenoid/Adenotonsillar Hypertrophy Group; Control Group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• Lack of written informed consent from a parent or legal guardian
• Control Group
• Age 3 to 18 years
• 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

Sponsors & Collaborators

• Harran University: lead

Study Sites (1)

Harran University Faculty of Medicine Hospital, Department of Otorhinolaryngology

Sanliurfa, Şanlıurfa, 63300, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral venous blood (serum) and unstimulated saliva samples.

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

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

Study Officials

• Servet Erdemes, MD

  Harran University

  PRINCIPAL INVESTIGATOR

• Mahmut Ağırtmış, MD

  Harran University

  STUDY DIRECTOR

Central Study Contacts

Mahmut Ağırtmış, MD

CONTACT

+905012392163; mahmutagirtmis@harran.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Otorhinolaryngology

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 21, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)