Leicester Sleep and Sugar Study

ISRCTN	ISRCTN39889125
DOI	https://doi.org/10.1186/ISRCTN39889125
Protocol serial number	3783
Sponsor	University Hospitals of Leicester NHS Trust (UK)
Funder	Biotechnology and Biological Science Research Council (BBSRC) (UK) (ref: PJMRM62078)

Submission date: 28/05/2010
Registration date: 28/05/2010
Last edited: 02/04/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Emer Brady
Scientific

Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom

Email	abc@email.com

Study information

Primary study design	Interventional
Study design	Single centre non-randomised interventional diagnosis, process of care and treatment trial
Secondary study design	Non randomised controlled trial
Scientific title	Leicester Sleep and Sugar Study
Study acronym	DRN074 (Leicester Sleep and Sugar Study)
Study objectives	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(s)	MREC approved (ref: 06/Q2501/97)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Participant HBA1c levels
Key secondary outcome measure(s)	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 assessmentinsulin resistance (HOMA-IR) analysis
Completion date	18/04/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	50
Key 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
Key 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
Date of first enrolment	29/11/2006
Date of final enrolment	18/04/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Leicester Royal Infirmary

Leicester
LE1 5WW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results in PhD thesis at		02/04/2020	Yes	No

Editorial Notes

02/04/2020: Publication reference added.
31/03/2020: No publications found, verifying study status with principal investigator.