A pilot study to look at the efficacy of a dietitian-led intervention using a homemade Very Low Calorie Diet (VLCD) to achieve prevention or remission of type 2 diabetes.
| ISRCTN | ISRCTN15555357 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15555357 |
| IRAS number | 292369 |
| Secondary identifying numbers | IRAS 292369 |
- Submission date
- 27/07/2021
- Registration date
- 07/09/2021
- Last edited
- 04/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Type 2 diabetes is a common condition that causes the level of sugar (glucose) in the blood to become too high.
This is a pilot study between the NHS and University of the Highlands and Islands to investigate the efficiency of a dietitian led, homemade, Very Low Calorie Diet (VLCD) on the prevention as well as reversal of type 2 diabetes.
Similar studies have shown the reversal of type 2 diabetes and we aim to see if prevention is possible.
Who can participate?
30 patients with pre-diabetes or early diagnosis (within 4 years) of type 2 diabetes, between the ages of 20 - 70 years, will be able to take part as long as they meet our inclusion criteria.
What does the study involve?
Over a total period of 48 weeks after recruitment, participants will go through 3 different Phases after recruitment.
• Recruitment: Consent, Blood samples and body measurements done.
• Phase 1: 12 weeks of homemade Very Low Calorie Diet. Bloods and body measurements done. Contact with study Dietitian every 2 weeks.
• Phase 2: 12 weeks of food reintroduction. Bloods and body measurements done. Contact with study Dietitian every 2 weeks.
• Phase 3: 12 weeks of Weight maintenance. Bloods and body measurements done.
At each stage, participants will be invited to attend the Diabetes Centre at the Centre for Health Science in Inverness for bloods and measurements to be done. Blood samples are taken by venepuncture by a qualified research nurse, and body measurements may be taken by the research nurse or study dietitian.
What are the possible benefits and risks of participating?
Blood samples are taken by venepuncture by a qualified research nurse, and body measurements may be taken by the research nurse or study dietitian.
Blood sample analysis will in the main be done by Raigmore hospital and the participant will be able to access these results through their GP. Any results which fall outside normal parameters will be reported by researchers to the Chief Investigator, Professor Sandra MacRury, Consultant Diabetologist, who will make the decision for the study dietitians to contact the participant or their GP.
Where is the study run from?
University of the Highlands and Islands (UK)
When is the study starting and how long is it expected to run for?
October 2020 to August 2023
Who is funding the study?
Scottish Government Diabetes Prevention Strategy Group (UK)
Who is the main contact?
Prof Sandra MacRury, sandra.macrury@uhi.ac.uk
Kirsty Hickson, kirsty.hickson@uhi.ac.uk
Contact information
Scientific
Institute of Health and Innovation
University of the Highlands and Islands
Centre for Health Science
Inverness
IV2 3JH
United Kingdom
 ORCID ID |
0000-0001-7599-1302 |
|---|---|
| Phone | +44 (0)1463 279583 |
| sandra.macrury@uhi.ac.uk |
Public
Institute of Health and Innovation
University of the Highlands and Islands
Centre for Health Science
Inverness
IN2 3JH
United Kingdom
| ORCID ID |
0000-0003-2450-5145 |
|---|---|
| Phone | +44 (0)1463 279575 |
| kirsty.hickson@uhi.ac.uk |
Study information
| Study design | Pilot single centre open interventional study with no control group |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Home |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | A pilot study to look at the efficacy of a dietitian-led intervention using a homemade Very Low Calorie Diet (VLCD) in patients with early Type 2 Diabetes or pre-diabetes, to achieve the outcomes of either prevention or remission of Type 2 Diabetes. |
| Study acronym | VLCD T2D |
| Study objectives | Homemade VLCD intervention and subsequent dietary input can prevent or reverse Type 2 Diabetes. |
| Ethics approval(s) | Approved 04/05/2021, North of Scotland Research Ethics Committee 1 (Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, UK; +44 (0)1224 558458, gram.nosres@nhs.scot), ref: 21/NS/0055 |
| Health condition(s) or problem(s) studied | Prevention or reversal of type 2 diabetes in participants with pre-diabetes or type 2 diabetes diagnosed within the previous 4 years. |
| Intervention | All participants will be recruited to the Homemade VLCD intervention and they will have baseline blood samples and anthropometric measurements done. In addition they will complete a health questionnaire and an eating habits questionnaire. There are 3 phases to the trial as follows. 1. 12 week VLCD intervention when all diabetes medication will be stopped. They will have contact with a study dietitian every 2 weeks. At week 4 they will complete a diet acceptability questionnaire. Blood samples and anthropometric measurements, they will complete a health questionnaire and an eating habits questionnaire at end of 12 weeks. 2. 12 week food reintroduction with dietetic guidance. They will again have contact with a study dietitian every 2 weeks. Blood samples and anthropometric measurements and they will complete a health questionnaire and an eating habits questionnaire at end of 12 weeks. 3. 12 weeks of weight management support, again contact with a study dietitian every 2 weeks. Bloods and anthropometric measurements at end of 12 weeks, and they will complete a health questionnaire and an eating habits questionnaire. Final bloods and anthropometric measurements and health questionnaire and eating habits questionnaire at end of 12 weeks (week 48 of study). |
| Intervention type | Behavioural |
| Primary outcome measure | 1. HbA1c is measured by Raigmore Hospital Biochemistry department at baseline, and 12, 24, 36, and 48 weeks. 2. Weight (kg) is measured at baseline, 12, 24, 36, and 48 weeks by NHS research nurse team staff using standard Diabetes clinic scales. 3. Waist circumference (cm) is measured at baseline, 12, 24, 36, and 48 weeks by NHS research nurse team staff using standard Diabetes clinic measuring tape. 4. BMI (kg/m²) is calculated, by research staff using height taken at baseline and weight at baseline 12, 24, 36, and 48 weeks. |
| Secondary outcome measures | 1. Redoxiperoxin and Glutathione is analysed by UHI Division of Biomedical Sciences by way of a novel ALISA technique, Antibody linked Oxi-State Assay and/or HPLC-ECD. All samples will be stored on arrival in the UHI labs and batch analysed at the end of the collection period. 2. Diet Acceptability is measured by way of questionnaire at 4 weeks. 3. Self regulation of eating is measured at baseline, 12, 24, 36, and 48 weeks by way of Self Regulation of Eating Behaviour questionnaire (SREBQ) 4. Quality of life is measured at baseline, 12, 24, 36, and 48 weeks by way of Health Questionnaire EQ-5D-5L |
| Overall study start date | 30/10/2020 |
| Completion date | 23/08/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 participants |
| Total final enrolment | 26 |
| Key inclusion criteria | 1. Informed written consent 2. Men and women with prediabetes (HbA1c 42 - 47 mmol/mol) 3. Men and women with Type 2 Diabetes, on diet, monotherapy or dual therapy within 4 years of diagnosis and not taking insulin 4. BMI >35kg/m² 5. Age 20 - 70years |
| Key exclusion criteria | 1. BMI < 35 kg/m² 2. HbA1c >100mmol/mol 3. Insulin use 4. Pregnant or planning pregnancy 5. Diagnosed eating disorder 6. Renal function eGFR <30ml/min 7. Myocardial Infarction (MI) withing previous 6 months 8. Severe heart failure 9. Taking part in another research study 10. Cancer 11. Liver disease but not excluding Non Alcoholic Fatty Livr Disease (NAFLD) 12. Severe depression and those on antipsychotic medication 13. History of substance misuse |
| Date of first enrolment | 01/06/2021 |
| Date of final enrolment | 01/08/2021 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Centre for Health Research
Old Perth Road
Inverness
IV2 3JH
United Kingdom
Sponsor information
University/education
Executive Office
12b Ness Walk
Inverness
IV2 3JH
Scotland
United Kingdom
| Phone | +44 (0)1463 279000 |
|---|---|
| donna.heddle@uhi.ac.uk | |
| Website | http://www.uhi.ac.uk/en |
"ROR" |
https://ror.org/02s08xt61 |
Hospital/treatment centre
NHS R&D
Centre for Health Science
Inverness
IV2 3JH
Scotland
United Kingdom
| Phone | +44 (0)1463 255822 |
|---|---|
| frances.hines@nhs.scot | |
| Website | https://www.nhshighland.scot.nhs.uk/ |
|
"ROR" |
https://ror.org/010ypq317 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
04/04/2024: The intention to publish date was changed from 30/03/2024 to 30/06/2024.
11/09/2023: The overall end date was changed from 18/08/2023 to 23/08/2023.
24/07/2023: The overall end date was changed from 30/07/2023 to 18/08/2023.
13/01/2023: Total final enrolment added.
13/12/2022: The following changes were made to the trial record:
1. The overall end date was changed from 30/12/2022 to 30/07/2023.
2. The intention to publish date was changed from 01/12/2023 to 30/03/2024.
3. The plain English summary was updated to reflect these changes.
01/10/2021: The sponsor contact has been updated.
31/08/2021: Trial's existence confirmed by NHS Grampian.
