Dietetic led study using VLCD for prevention of type 2 diabetes V1.0
Research type
Research Study
Full title
A Pilot study to investigate the efficacy of a dietetic led intervention using home made Very Low calorie Diet (VLCD) to achieve prevention or remission of type 2 diabetes
IRAS ID
292369
Contact name
Sandra MacRury
Contact email
Sponsor organisation
University of the Highlands and Islands
ISRCTN Number
ISRCTN15555357
Duration of Study in the UK
1 years, 3 months, 1 days
Research summary
This is a pilot study between the NHS and University of the Highlands and Islands to investigate the efficiency of a dietitian led, home made, Very Low Calorie Diet(VLCD)on the prevention as well as reversal of type 2 diabetes. \n\nSimilar studies have shown the reversal of type 2 diabetes and we aim to see if prevention is possible.\n\n30 patients with pre-diabetes or early diagnosis (within 4 years) of type 2 diabetes will be recruited from GP practices and provided with an information pack containing an invitation letter, Participant Information sheet and Quality of life questionnaire. They will be asked to attend the Diabetes Clinic at the Centre for Health Science for an initial visit where they will meet the research nurse from RD&I and study dietitian. Here they will be consented into the study and have their height, weight and waist circumference measured by the research nurse or study dietitian. \n2 vials of 5ml blood will be taken by the nurse, one to go to the NHS for HbA1c and LFT analysis and one to UHI for oxidative stress marker analysis. In addition, they will have their first dietetic consultation either face to face or remotely by NHS Clinic Near Me.\n\nWe will investigate the success of the intervention and the palatibility of the VLCD using body measurements, blood pressure measurements and Quality of Life questionnaires, as well as a brief diet history pre and post study. We will also be analysing blood samples for HbA1c and LFT in Raigmore biochemistry labs, and oxidative stress markers, Glutathione and Peroxyredoxin2 in UHI Biomedical labs pre, during and post study. Possibly also Neoteryx kit.\n\nAll data will be anonymised and kept securely on UHI servers in password protected files and all paper documents will be stored in a Project File in a locked filing cabinet.\n
REC name
North of Scotland Research Ethics Committee 1
REC reference
21/NS/0055
Date of REC Opinion
30 Apr 2021
REC opinion
Favourable Opinion