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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Rakesh Bhattacharjee, MD
- Telefoonnummer: 858-966-5846
- E-mail: rakesh@ucsd.edu
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
Andere namen:
|
|
Actieve vergelijker: 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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Peripheral Arterial Tonometry - Reactive Hyperemic Index
Tijdsspanne: At baseline.
|
EndoPAT
|
At baseline.
|
|
Peripheral Arterial Tonometry - Reactive Hyperemic Index
Tijdsspanne: At three months.
|
EndoPAT
|
At three months.
|
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Peripheral Arterial Tonometry - Reactive Hyperemic Index
Tijdsspanne: At six months.
|
EndoPAT
|
At six months.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
miRNA 92a and miRNA 210 levels
Tijdsspanne: At baseline.
|
Serum and Extracellular Vesicle derived miR 92a and miR 210 levels
|
At baseline.
|
|
miR 92a and miR 210 levels
Tijdsspanne: At three months.
|
Serum and Extracellular Vesicle derived miR 92a and miR 210 levels
|
At three months.
|
|
miR 92a and miR 210 levels
Tijdsspanne: At six months.
|
Serum and Extracellular Vesicle derived miR 92a and miR 210 levels
|
At six months.
|
Medewerkers en onderzoekers
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 170408
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
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IPD-toegangscriteria voor delen
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- MVO
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