Leicester Sleep and Sugar Study
| ISRCTN | ISRCTN39889125 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39889125 |
| Secondary identifying numbers | 3783 |
- 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
Scientific
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom
| abc@email.com |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 29/11/2006 |
| Completion date | 18/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Planned sample size: 50; UK sample size: 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
- England
- United Kingdom
Study participating centre
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom
LE1 5WW
United Kingdom
Sponsor information
University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
England
United Kingdom
| Website | http://www.uhl-tr.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/02fha3693 |
Funders
Funder type
Research council
Biotechnology and Biological Science Research Council (BBSRC) (UK) (ref: PJMRM62078)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
