Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
3783
Study information
Scientific title
Acronym
DRN074 (Leicester Sleep and Sugar Study)
Study hypothesis
Obstructive sleep apnoea (OSA) is a significant medical problem that affects approximately 4% of middle aged males and approximately 2% of adult females. Previous studies have highlighted the association between OSA and obesity, hypertension, insulin resistance and dyslipidemia, a cluster similar to that seen in the metabolic syndrome (MetS). The MetS itself is a significant risk factor for the development of type 2 diabetes (T2DM), cardiovascular disease (CVD) and cardiovascular mortality.
Sub-clinical systemic inflammation has been consistently observed in patients with T2DM and in those with the MetS. A number of inflammatory mediators, e.g., tumour necrosis factor-alpha (TNF-a), interleukin-6 (IL-6) have shown to be positively correlated with glucose intolerance and sleep deprivation. The association between inflammation and the pathogenesis of diseases such as T2DM, CVD and OSA is currently a pivotal area of research today.
The aim of this pilot study is to further establish the association between inflammatory mediators and poor sleep quality in a multiethnic population. In addition to investigating the positive effect that restoration of sleep has on glycemic control and inflammatory biomarkers that are associated with T2DM, CVD and MetS through continuous positive airway pressure (CPAP) therapy.
Ethics approval
MREC approved (ref: 06/Q2501/97)
Study design
Single centre non-randomised interventional diagnosis, process of care and treatment trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Topic: Diabetes Research Network; Subtopic: Type 2; Disease: Cardiovascular disease, Multiple complications
Intervention
To measure the effect that sleep restoration (via CPAP) has on glucose tolerance and inflammation based on change in HBA1c levels and change in the level of recognised inflammatory biomarkers.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Participant HBA1c levels
Secondary outcome measures
1. Participant plasma levels of recognised inflammatory biomarkers
2. Participant compliance with CPAP
3. Participant Epworth Sleepiness Scale (ESS), Hospital Anxiety and Depression Scale (HADS) and Quality of Life (QoL) scores
4. Participant glycaemic control via capillary blood glucose monitoring (CBGM) results
5. Participant insulin sensitivity via homeostasis model assessment–insulin resistance (HOMA-IR) analysis
Overall trial start date
29/11/2006
Overall trial end date
18/04/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Body mass index (BMI) greater than or equal to 35 kg/m^2
2. Established type 2 diabetes (greater than 3 months)
3. Undiagnosed obstructive sleep apnoea
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Planned sample size: 50; UK sample size: 50
Participant exclusion criteria
1. BMI less than 35 kg/m^2
2. Diagnosed with type 2 diabetes within last 3 months
3. Diagnosis of obstructive sleep apnoea
Recruitment start date
29/11/2006
Recruitment end date
18/04/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom
Sponsor information
Organisation
University Hospitals of Leicester NHS Trust (UK)
Sponsor details
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research council
Funder name
Biotechnology and Biological Science Research Council (BBSRC) (UK) (ref: PJMRM62078)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary