Obstructive Sleep Apnoea in Patients With Type 1 Diabetes
Obstructive Sleep Apnoea (OSA) in Patients With Type 1 Diabetes (T1D): A Cross-Sectional Study
The primary aim of this study is to assess the relationship between obstructive sleep apnoea (OSA) and cardiac autonomic neuropathy (CAN) in patients with T1D.
The secondary aims of this study are to assess: (1) the prevalence of OSA in patients with T1D; (2) the relationship between OSA and metabolic parameters (such as glycaemic control, blood pressure, lipids and weight) in patients with T1D; (3) the relationship between OSA and diabetes-related microvascular complications (retinopathy, nephropathy, peripheral neuropathy) in patients with T1D; and (4) the potential mechanisms for the relationship between OSA and diabetic-related complications if such a relationship is found.
Visão geral do estudo
Status
Condições
Descrição detalhada
Obstructive sleep apnoea (OSA) has been reported to be very common in patient with type 2 diabetes (T2D), and this relation is expected as both conditions share obesity as a common risk factor. Despite that several articles have stated that OSA is an independent risk factor for abnormal glucose metabolism, hypertension, and cardiovascular diseases.
In contrast, patients with type 1 diabetes (T1D) are leaner and younger than patients with T2D, so it was expected that OSA might be less common in patients with T1D. However, few studies have reported the prevalence of OSA in T1D with a range between 8 and 46%. The relationship between OSA and diabetes-related vascular disease is poorly explored in patients with T1D. This suggests a mechanism other than obesity may be responsible for OSA in patients with T1D. Therefore, the investigators hypothesized that (1) OSA is related to CAN rather than obesity in patients with T1D. (2) OSA is common in patients with T1D. (3) OSA is associated with worse metabolic profile and microvascular complications in T1D. (4) Oxidative and nitrosative stress are possible mechanisms relating OSA to T1D complication.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
-
Birmingham, Reino Unido, B9 5SS
- Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- T1DM patient aged 18 and above, who was diagnosed more than 4 years ago.
- Able to give informed consent.
- Has sufficient proficiency in English to verbally answer interview questions.
Exclusion Criteria:
- Past medical history of severe respiratory disorders including treated OSA.
- Patients using oxygen supplements.
- Patients with end-stage renal disease receiving dialysis.
- Pregnancy.
- Dementia.
- End stage diseases with life expectancy below 6 months.
- Patients with implantable devices
- Patients with known atrial fibrillation
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The relationship between OSA and cardiac autonomic neuropathy (CAN) in patients with T1D.
Prazo: Single time point measurement (20- 30 min)
|
CAN will be assessed using heart rate variability (HRV) and spectral analysis. During this test blood pressure and electrocardiogram (ECG) and will be recorded while resting in a sitting down position and during certain manoeuvres that include deep breathing and Valsalva, and standing up. The Result of this outcome will be categorized into normal, borderline, or abnormal. This study is one visit only, and the total duration of the visit is 2-4 hours. The time frame below is the approximate time needed to collect each outcome data. |
Single time point measurement (20- 30 min)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The prevalence of obstructive sleep apnoea in patients with T1D.
Prazo: Single time point measurement (over 8 hours) at participant residence
|
Sleep apnoea will be assessed using portable multi-channel home-based sleep device.
|
Single time point measurement (over 8 hours) at participant residence
|
|
The relationship between the presence of OSA and metabolic profile in patients with T1D.
Prazo: Single time point measurement (15 min)
|
This outcome will be assessed by comparing the routine assessment results for patients with OSA to patients without OSA.
|
Single time point measurement (15 min)
|
|
The relationship between OSA and the presence of microvascular complications in T1D patients.
Prazo: Single time point measurement (1-2 hours)
|
Microvascular complications include diabetic neuropathy, diabetic nephropathy, and diabetic retinopathy.
|
Single time point measurement (1-2 hours)
|
|
The potential mechanisms for the relationship between OSA and diabetic-related complications
Prazo: Single time point measurement (about 5 min)
|
Will be assessed using serum and plasma blood samples.
|
Single time point measurement (about 5 min)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Abd Tahrani, MD, NIHR Clinician Scientist at University of Birmingham
Publicações e links úteis
Publicações Gerais
- Borel AL, Benhamou PY, Baguet JP, Halimi S, Levy P, Mallion JM, Pepin JL. High prevalence of obstructive sleep apnoea syndrome in a Type 1 diabetic adult population: a pilot study. Diabet Med. 2010 Nov;27(11):1328-9. doi: 10.1111/j.1464-5491.2010.03096.x. No abstract available.
- Reutrakul S, Van Cauter E. Interactions between sleep, circadian function, and glucose metabolism: implications for risk and severity of diabetes. Ann N Y Acad Sci. 2014 Apr;1311:151-73. doi: 10.1111/nyas.12355. Epub 2014 Mar 14.
- Golbidi S, Badran M, Ayas N, Laher I. Cardiovascular consequences of sleep apnea. Lung. 2012 Apr;190(2):113-32. doi: 10.1007/s00408-011-9340-1. Epub 2011 Nov 3.
- Manin G, Pons A, Baltzinger P, Moreau F, Iamandi C, Wilhelm JM, Lenoble P, Kessler L, Kessler R. Obstructive sleep apnoea in people with Type 1 diabetes: prevalence and association with micro- and macrovascular complications. Diabet Med. 2015 Jan;32(1):90-6. doi: 10.1111/dme.12582. Epub 2014 Sep 25.
- Schober AK, Neurath MF, Harsch IA. Prevalence of sleep apnoea in diabetic patients. Clin Respir J. 2011 Jul;5(3):165-72. doi: 10.1111/j.1752-699X.2010.00216.x. Epub 2010 Jun 30.
- Tahrani AA. Obstructive sleep apnea in patients with diabetes: implications for clinical practice. Diabetes Management. 2015; 5(6):511-23. doi: 10.2217/dmt.15.34.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
- Distúrbios do Metabolismo da Glicose
- Doenças Metabólicas
- Doenças do Sistema Nervoso
- Doenças Respiratórias
- Doenças do sistema imunológico
- Doenças autoimunes
- Distúrbios Respiratórios
- Distúrbios do Sono Intrínsecos
- Dissônias
- Distúrbios do Sono Vigília
- Doenças do Sistema Endócrino
- Sinais e Sintomas Respiratórios
- Síndromes da Apneia do Sono
- Apnéia do Sono, Obstrutiva
- Diabetes Mellitus
- Diabetes Mellitus, Tipo 1
- Apnéia
Outros números de identificação do estudo
- RG_16-154
- 209532 (Outro identificador: Integrated Research Approval System (IRAS))
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Diabetes tipo 1
-
Oxford Brookes UniversityUniversity of OxfordConcluídoAtividade física | Saúde Mental Bem-estar 1 | Função Cognitiva 1, Social | Academic Attainment | Fitness TestingReino Unido
-
SanionaConcluído
-
Calliditas Therapeutics ABEurofins Optimed; York Bioanalytical SolutionConcluído
-
Calliditas Therapeutics ABConcluído
-
Merck Sharp & Dohme LLCRecrutamentoCâncer de Pulmão de Células Não Pequenas | Tumores Sólidos | Morte Celular Programada-1 (PD1, PD-1) | Ligante 1 de morte celular programada 1 (PDL1, PD-L1) | Ligante 2 de morte celular programada 1 (PDL2, PD-L2)Japão
-
National Cancer Institute, NaplesRecrutamentoCâncer de Ovário Recorrente Sensível à Platina BRCA Wild TypeItália
-
Rambam Health Care CampusIsrael Science FoundationConcluído
-
Alvotech Swiss AGConcluído
-
PfizerConcluído
-
JKT Biopharma Co., Ltd.Recrutamento