Extracellular microRNA: Biomarkers of Endothelial Dysfunction in Obese Adolescents & Adults With Obstructive Sleep Apnea
Extracellular Micro RNA (miR) (Extracellular Vesicle (EV)-Associated & Non-EV-associated miRs) Identify and Mediate Endothelial Dysfunction in Obesity and Obstructive Sleep Apnea in Adolescents & Young Adults
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Investigators will randomize 100 OSA patients (age 13-21) to receive either continuous positive airway pressure (CPAP) plus baseline diet/exercise (n=50) or medical management (intensive diet and exercise; n=50). Only children in whom adenotonsillectomy is contraindicated (morbid obesity, history of adenotonsillectomy, lack of adenotonsillar hypertrophy) will be included. Investigators will conduct a randomized prospective comparative effectiveness study to assess the impact of treatment on OSA on endothelial function (peripheral arterial tonometry-EndoPAT). In addition to diagnostic polysomnography and EndoPAT at baseline, EV (extracellular vesicle) and non EV derived miR 92a/miR 210 concentrations, inflammatory cytokines concentrations, and body anthropometry will be measured. Following 3 mos of therapy and after 6mos of therapy, investigators will re-evaluate EndoPAT, EV and non EV derived miR 92a/miR 210 concentrations, inflammatory cytokines, and body anthropometry.
Throughout the study, investigators will maintain weekly telephone contact and monthly face-to-face visits as per standard of care in both groups to ensure ongoing success. In the medical management group (intensive diet and exercise), diet and exercise will be tracked by maintaining weekly telephone contact and monthly face-to-face visits with a registered dietician. For the CPAP group, investigators will also maintain weekly telephone contact and monthly face-to-face visits with a sleep technician to review mask fitting, and adherence reports, to optimize adherence to CPAP therapy.
Following completion at six months, polysomnography will be repeated.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Rakesh Bhattacharjee, MD
- Numéro de téléphone: 858-966-5846
- E-mail: rakesh@ucsd.edu
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Otherwise healthy children and young adults with a diagnosis of obstructive sleep apnea based on polysomnography criteria of an obstructive apnea hypopnea index > 10 events/hr.
- For children a BMI range up to 99.7% and for adults BMI up to 32 kg/m2 is used.
Exclusion Criteria:
- The presence of elevated blood pressure
- The presence of diabetes or pre-diabetes
- The presence of craniofacial anomalies
- The presence of neuromuscular disorders
- The presence of syndromic or defined genetic abnormalities
- Pregnancy
- History of smoking (any smoking within the prior 6 mos or >5 pack years total)
- The presence of infectious disease (e.g. including hepatitis B, C, HIV etc.)
- The presence of collagen vascular disease (e.g. lupus, arthritis, scleroderma, polymyositis, mixed-connective tissue disease, vasculitis etc)
- The presence of hepatic disease (including hepatitis fatty liver or cirrhosis)
- The presence of renal disease (including azotemia or clinical proteinuria)
- The presence of cardiopulmonary disease (e.g. known asthma, cystic fibrosis, congenital heart disease)
- Individuals using medications which could affect sleep or breathing (including hypnotics)
- Individuals using chronic anti-inflammatory therapy
- Individuals with any subjects with acute or chronic illness.
- Individuals using anti-hypertensive therapies
- Children with a a BMI > 99.7%
- Adults with a BMI > 32 kg/m2
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: CPAP
This arm will consist of patients with obstructive sleep apnea who will be asked to use CPAP nightly to treat their OSA for six months
|
This device delivers air pressure non invasively through a mask to stent open the upper airway to prevent obstruction during sleep.
This is an FDA approved device that has been used for several decades to treat OSA.
Autres noms:
|
|
Comparateur actif: Diet and Exercise
This arm will consist of patients with obstructive sleep apnea who will be asked to engage in dietary management and regular exercise for six months.
|
This will consist of weekly telephone and monthly face to face visits to monitor and suggest measures to improve diet and regular exercise as conducted by a registered dietician.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Peripheral Arterial Tonometry - Reactive Hyperemic Index
Délai: At baseline.
|
EndoPAT
|
At baseline.
|
|
Peripheral Arterial Tonometry - Reactive Hyperemic Index
Délai: At three months.
|
EndoPAT
|
At three months.
|
|
Peripheral Arterial Tonometry - Reactive Hyperemic Index
Délai: At six months.
|
EndoPAT
|
At six months.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
miRNA 92a and miRNA 210 levels
Délai: At baseline.
|
Serum and Extracellular Vesicle derived miR 92a and miR 210 levels
|
At baseline.
|
|
miR 92a and miR 210 levels
Délai: At three months.
|
Serum and Extracellular Vesicle derived miR 92a and miR 210 levels
|
At three months.
|
|
miR 92a and miR 210 levels
Délai: At six months.
|
Serum and Extracellular Vesicle derived miR 92a and miR 210 levels
|
At six months.
|
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 170408
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Intellectual property and data generated under this project will be administered in accordance with both University and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance of March 5, 2003.
As a part of this application will involve human subjects, investigators believe that the rights and privacy of people who will participate in the research project must be protected at all times. In case other investigators express interest in working with the data, every effort will be made to provide the data to them free of identifiers. However, such endeavors will have to be individually considered and also approved by the University of California (UC) San Diego Human Research Protection Program before any commitments can be made.
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- RSE
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