NCT02403141

Brief Summary

Obstructive sleep apnoea (OSA) is a common medical problem which, despite increasing awareness, remains under-diagnosed. There is a close association between OSA and obesity; 60-70% of patients diagnosed with OSA are either obese or overweight \[1\]. OSA is also very common among patients with type 2 diabetes. Type 2 Diabetes Mellitus (T2DM) has reached epidemic status in the Gulf region. OSA worsens insulin resistance and leads to weight gain through sleep disturbance \[2\]. Several mechanisms have been proposed for the associations of OSA with diabetes and obesity \[3\]. At present there is little available information regarding the prevalence of OSA in the UAE, the relationship with T2DM and obesity, and the impact of OSA on health outcomes in the Emirati population. This research will explore these relationships and inform public health decisions regarding diagnostic pathways, service provision and treatment protocols.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

March 25, 2015

Last Update Submit

March 1, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Primary objective (Establishing the prevalence of OSA in the study population.)

    Establishing the prevalence of OSA in the study population.

    3 months

Study Arms (4)

Normal glucose tolerance

Patients with normal fasting glucose. Blood glucose less than 5.6mmol/L

Other: Questionnaire

Impaired fasting glycaemia

Patients with blood glucose between 5.6mmol/L - 7mmol/L

Other: Questionnaire

Type 2 diabetes

Patients with blood glucose higher than 7mmol/L and negative IA2 and GAD antibodies.

Other: Questionnaire

Type 1 diabetes

Patients on insulin and with positive IA2 and/or GAD antibodies.

Other: Questionnaire

Interventions

Impaired fasting glycaemiaNormal glucose toleranceType 1 diabetesType 2 diabetes

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients over the age of 18 attending ICLDC will be offered the option of taking part in the study. Those agreeing to participate will be asked to fill in a questionnaire.

You may qualify if:

  • Participants aged between 18-64 years old. Both Gender male and female.

You may not qualify if:

  • Paediatrics below the age of 18. Any participant who is unable to take part

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London Diabetes Centre

Abu Dhabi, P.O Box 48338, United Arab Emirates

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Endocrinologist

Study Record Dates

First Submitted

March 25, 2015

First Posted

March 31, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 3, 2017

Record last verified: 2017-03

Locations