Condition category
Nervous System Diseases
Date applied
28/05/2010
Date assigned
28/05/2010
Last edited
29/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Emer Brady

ORCID ID

Contact details

Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom

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

http://www.uhl-tr.nhs.uk/

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

Publication citations

Additional files

Editorial Notes