Pre Diabetes Randomised Control Trial Feasibility Study Version 1
Research type
Research Study
Full title
Assessing the feasibility of conducting a randomised control trial to evaluate the effectiveness of a 15-minute one-to-one consultation to improve blood glucose control in pre-diabetes
IRAS ID
239910
Contact name
Nicholas Gregory
Contact email
Sponsor organisation
Aberystwyth University
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 31 days
Research summary
Pre-diabetes is defined as a higher than normal blood glucose level and is associated with an increased risk of developing diabetes. Complications of diabetes, including heart problems, blindness and risk of amputation develop over time, so it’s beneficial to delay the onset of diabetes for as long as possible. This study will assess the feasibility of conducting a large scientific trial to evaluate the effectiveness of a 15-minute one-to-one consultation aimed to improve blood sugar control in patients with pre-diabetes. The consultation will be formed of a 15-minute one-to-one discussion between a health-care professional and the patient in a GP surgery. Patients between the ages of 18-80 who are at increased risk of diabetes will be identified by their surgery and will be invited to take part. They will attend a testing session at a university research unit before the consultation and then placed at random into either the ‘consultation’ or ‘control’ group. Patients in the consultation group will receive the 15 minute one-to-one consultation. Patients in the control group will not. All patients will attend further testing sessions at the university research unit after three and six months. Body weight, height, waist and hip size, blood pressure and body composition will be recorded and blood analysed for glucose, cholesterol and dietary components. For a three-week period following each visit, nine urine samples will be collected on different days and physical activity will be recorded. Urine will be analysed to provide an indication of the patient’s diet over a three-week period. Primary objectives are to assess the effectiveness of the recruitment strategy and willingness of patients to engage in, and adhere to, the research study and understand the impact of the consultation on health measures.
REC name
Wales REC 7
REC reference
18/WA/0041
Date of REC Opinion
26 Feb 2018
REC opinion
Favourable Opinion