DRN 725: Chronic Disease Resource Centre Diabetes Division
| ISRCTN | ISRCTN17526370 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17526370 |
| Secondary identifying numbers | 12984 |
- Submission date
- 19/11/2012
- Registration date
- 27/03/2013
- Last edited
- 27/03/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
The study aims to recruit individuals with diabetes or a pre-diabetic condition. We will collect information and blood samples from patients once a year at a time convenient to the individual and the research team (normally at the same time as their annual diabetes check). The information collected from this study will be used in research into how diabetes affects individuals in the setting of it being a chronic disease. The aim of this study is to establish a database of information of adult participants diagnosed with impaired glucose tolerance. This database will be used to explore the psycho-social aspects of diabetes in the context of it being a chronic disease. Also, the database will be used to develop partnerships with other researchers to advance diabetes research for the benefit of individuals with diabetes.
Who can participate?
Individuals who are 18 years or older with confirmed diabetes or abnormal glucose tolerance. Individuals must be willing and able to attend annual appointments at clinical study recruitment site centre.
What does the study involve?
The study involves an annual study visit where non-invasive clinical measurements will be taken, along with a questionnaire, blood and urine samples.
What are the possible benefits and risks of participating?
As this study is does not involve any intervention then the risks to participants are minimal.
Where is the study run from?
The study is currently run from the Queen Elizabeth Hospital Birmingham, UK. There is a network of other centres throughout the West Midlands who are also participating in this study.
When is the study starting and how long is it expected to run for?
The study started in September 2012 and is expected to run until April 2022.
Who is funding the study?
Novo Nordisk A/S (USA)
Who is the main contact?
Jayne Robbie
Diabetes Research Unit
Nuffield House
Queen Elizabeth Hospital
Birmingham B15 2TH
UK
Contact information
Scientific
University of Birmingham
Institute of Biomedical Research
Division of Immunity and Infection
Medical School
Edgbaston
Birmingham
B15 2TT
United Kingdom
| p.narendran@bham.ac.uk |
Study information
| Study design | Non-randomised observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Chronic Disease Resource Centre: What is the natural history of diabetes and its complications? |
| Study objectives | The aim of this study is to establish a prospective, observational multi-ethnic cohort of adult participants diagnosed with impaired glucose tolerance. The cohort will encourage academic collaboration for patient benefit and will be characterised by anthropometry, questionnaires, biological samples and co-morbidities forming a resource for epidemiological, clinical and health service research. The study will aim to recruit all eligible participants from across the West Midlands Birmingham area. A 10 year study will be undertaken to recruit and follow-up 1000 participants, concentrating initially on University Hospitals Birmingham NHS Foundation Trust (UHBFT), before but could be opening to other NHS clinical centres trusts interested in collaborating. In addition to providing information about the natural history and progression of diabetes, development of complications and co-morbidities it will provide unique information for use in the detection of biomarkers to help predict the progression of complications and to monitor the effectiveness of interventions. Also, the study will try to accurately categorise patients with potentially different types of diabetes in order to determine whether any factors significantly affect their long-term morbidity or mortality. In summary the overarching aims and objectives of this study is: 1. To understand the natural history of diabetes in our local population. To determine the incidence of other chronic medical conditions in patients with diabetes. 2. Provide a repository of information for future analysis to help determine potential biomarkers of chronic diseases related to diabetes. More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12984 |
| Ethics approval(s) | NRES Committee West Midlands - Staffordshire, 8th May 2012, ref: 12/WM/0089 |
| Health condition(s) or problem(s) studied | Diabetes Research Network |
| Intervention | The study is observing changes in participants with diabetes in several domains: depression, quality of life, eating behaviour, risk of sleep apnoea, activities of daily living, employment and productivity, as well as developing a repository of biological samples. The tests will include routine clinical assessment, bone, liver, renal, thyroid blood tests, and questionnaires. Patients will also be invited to undertake more significant testing including analysis of saliva samples, AGE reader, pancreatic stimulation tests. |
| Intervention type | Other |
| Primary outcome measure | Micro and macro vascular complications measured at 10 years |
| Secondary outcome measures | Qualitative and questionnaire based assessment of diabetes related endpoints measured at 10 years |
| Overall study start date | 06/09/2012 |
| Completion date | 01/04/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 1000 |
| Key inclusion criteria | 1. Male or female, age >= 18 years 2. Confirmed diagnosis of diabetes or prediabetes 3. Individuals freely able to attend appointments at the Chronic Disease Research Centre 4. Individuals who are able to undergo the appropriate investigations |
| Key exclusion criteria | 1. Individuals unable to attend for research visits 2. Individuals who in the clinicians opinion is not appropriate for recruitment into this study |
| Date of first enrolment | 06/09/2012 |
| Date of final enrolment | 01/04/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
B15 2TT
United Kingdom
Sponsor information
University/education
Department of Primary Care & General Practice
Primary Care Clinical Sciences Building
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Website | http://www.birmingham.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Industry
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 |
