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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Rakesh Bhattacharjee, MD
- Número de telefone: 858-966-5846
- E-mail: rakesh@ucsd.edu
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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
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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.
Outros nomes:
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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Peripheral Arterial Tonometry - Reactive Hyperemic Index
Prazo: At baseline.
|
EndoPAT
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At baseline.
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Peripheral Arterial Tonometry - Reactive Hyperemic Index
Prazo: At three months.
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EndoPAT
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At three months.
|
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Peripheral Arterial Tonometry - Reactive Hyperemic Index
Prazo: At six months.
|
EndoPAT
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At six months.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
miRNA 92a and miRNA 210 levels
Prazo: At baseline.
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Serum and Extracellular Vesicle derived miR 92a and miR 210 levels
|
At baseline.
|
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miR 92a and miR 210 levels
Prazo: At three months.
|
Serum and Extracellular Vesicle derived miR 92a and miR 210 levels
|
At three months.
|
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miR 92a and miR 210 levels
Prazo: At six months.
|
Serum and Extracellular Vesicle derived miR 92a and miR 210 levels
|
At six months.
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Antecipado)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 170408
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CSR
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