Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/11/2012
Date assigned
27/03/2013
Last edited
27/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Parth Narendran

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12984

Study information

Scientific title

Chronic Disease Resource Centre: What is the natural history of diabetes and its complications?

Acronym

Study hypothesis

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

NRES Committee West Midlands - Staffordshire, 8th May 2012, ref: 12/WM/0089

Study design

Non-randomised observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

06/09/2012

Overall trial end date

01/04/2022

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 1000

Participant 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

Recruitment start date

06/09/2012

Recruitment end date

01/04/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Birmingham
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Department of Primary Care & General Practice
Primary Care Clinical Sciences Building
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

http://www.birmingham.ac.uk/

Funders

Funder type

Industry

Funder name

Novo Nordisk A/S (UK)

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