Study to determine the feasibility and acceptability of an intensive weight management programme to achieve remission of diabetes in patients of South Asian ethnicity
| ISRCTN | ISRCTN10720065 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10720065 |
| Secondary identifying numbers | GN16DI505 |
- Submission date
- 11/09/2017
- Registration date
- 27/09/2017
- Last edited
- 14/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
In Scotland, around 1% of the population are of South Asian ethnicity. People of South Asian origin are at higher risk of type 2 diabetes (T2DM), and develop the condition at a lower body weight than those of non-South Asian origin. T2DM is a condition that causes blood sugar to be too high. This, coupled with evidence that people of South Asian origin are less likely to access weight-management services, points to a need for a new weight management approach to manage the growing problem in this population. Published research in people of European origin demonstrates low/very low energy diets, achieving weight loss in the region of 15kg (2-3 stones), results in diabetes remission in a significant proportion of individuals with T2DM. The Diabetes Remission Clinical Trial (DiRECT) is currently underway in Tyneside and Scotland to assess long-term outcomes of this treatment approach in primary care. However, to date, research using this approach, has not been conducted with patients of South Asian origin. An existing evidence -based weight management programme, ‘Counterweight-Plus’, that initially focuses on a low energy liquid formula diet, is showing promising results in terms of acceptability, weight change and impact on diabetic status. However as the approach must be acceptable to the population being studied, the aim of this feasibility study is to examine if the initial phase of this programme using formula food products is acceptable to the South Asian population, and if it results in similar clinical outcomes in terms of weight loss and diabetic remission at 3-6 months. The study will provide data to support implementation of a larger study aimed at long-term weight change in this population.
Who can participate?
Patients aged 18 to 65 years old of South Asian origin in participating GP practices in Glasgow, diagnosed with type 2 diabetes within the previous 2 years, will be invited to participate.
What does the study involve?
Patients recruited from participating GP practices in Glasgow are randomly allocated to one of two groups. Those in the first group commence the Counterweight Plus weight management programme immediately. This is delivered by research Dietitians experienced in programme delivery. Participants in the second group are advised to continue with usual care for three months before returning to receive the intervention.
What are the possible benefits and risks of participating?
There will be multiple clinical and personal benefits from any degree of weight loss achieved by participants. For those who are successful in achieving >15kg it is expected that that many will revert to a non-diabetic state.There are no major risks from taking part in this study. The only significant risk from more intensive weight loss is that gallstones may become symptomatic. This is still relatively uncommon and the risk will be minimised by the dietary provision which includes some fat consumption.
Where is the study run from?
Glasgow Royal Infirmary (UK)
When is the study starting and how long is it expected to run for?
October 2016 to February 2022 (updated 20/11/2021, previously: December 2021; updated 19/04/2021, previously: December 2022; updated 30/03/2021, previously: September 2021))
Who is funding the study?
Investigator initiated and funded (UK)
Who is the main contact?
Professor Mike Lean
Dr Wilma Leslie
Contact information
Scientific
Department of Human Nutrition
University of Glasgow
Glasgow Royal Infirmary
Glasgow
G31 2ER
United Kingdom
| Phone | +44 (0)141 201 8508 |
|---|---|
| Mike.Lean@glasgow.ac.uk |
Public
Dept of Human Nutrition
University of Glasgow
Glasgow Royal Infirmary
Glasgow
G31 2ER
United Kingdom
| Phone | +44 (0)141 201 8609 |
|---|---|
| Wilma.Leslie@glasgow.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | SouTh AsiAN Diabetes Remission Feasibility Trial |
| Study acronym | STANDby |
| Study hypothesis | Losing weight using a structured weight management programme which includes an initial period of total diet replacement, followed by carefully managed food reintroduction and then weight loss maintenance, is a viable treatment for putting T2DM into remission, and can potentially be transferred to a larger scale as part of routine GP care, where large numbers of overweight people with T2DM are managed in the UK. |
| Ethics approval(s) | WEST 3 Research Ethics Committee, 07/06/2017, ref: 17/WS/0104 |
| Condition | Type 2 diabetes |
| Intervention | The study follows a randomised controlled design. A blinded envelope system is used for treatment allocation. Participants randomised to control group continue with usual care for three months before returning to receive the intervention. Participants randomised to intervention group commence the Counterweight Plus weight management programme immediately. The weight management intervention programme is called Counterweight Plus, which includes an initial Total Diet Replacement (TDR) phase followed by structured food reintroduction. The intervention is delivered by research Dietitians experienced in programme delivery. TDR phase (0 to 12-20 weeks): A commercial micronutrient-replete 825-853kcal/d LELD is provided (Counterweight Pro 800) to replace normal foods, with ample fluids, for 12-20 weeks. Participants return for review one week after commencing the TDR and at 2-weekly intervals thereafter until starting the food reintroduction stage. Food Reintroduction (FR) phase (weeks 12-18): A stepped transition to food based Weight Maintenance, replacing TDR with meals which contain 30% of energy from fat. Some further modest weight loss occurs. During this phase participants attend for review appointments every two weeks. On completion of the feasibility study, (at the end of FR), participants are offered the option to join the BEYOND Weight Loss Maintenance study currently running and recruiting patients from the Glasgow Clinical Research Facility. Participants have magnetic resonance measurements of pancreas and liver fat taken at baseline and again at the point of maximal weight loss. |
| Intervention type | Mixed |
| Primary outcome measure | 1. Number recruited to the study: analysis of trial data, at close of recruitment period, on number consented into study 2. Weight loss achieved, and changes in diabetes status: measurement of body weight and HbA1c at baseline, end of total diet replacement phase, and completion of intervention 3. Programme retention: analysis of trial data, at close of study, on number of participants completing the intervention 4. Acceptability of the intervention to people of South Asian origin measured using a process evaluation questionnaire on completion of intervention 5. Definition of the mechanisms behind type 2 diabetes remission in the South Asian population is measured using MRI scanning at baseline and point of maximal weight loss |
| Secondary outcome measures | Quality of life is measured using the EQ-5D-3L questionnaire at baseline and end of intervention |
| Overall study start date | 07/10/2016 |
| Overall study end date | 28/02/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 25 |
| Total final enrolment | 25 |
| Participant inclusion criteria | 1. Inclusion criteria 2. Written informed consent 3. Men and women aged 18-65 years 4. South Asian ethnicities 5. Body mass index (BMI)>25 kg/m2 and <45 kg/m2 6. T2DM of duration 0-2years (diagnosis based on a recorded diagnostic-level test: HbA1c and/or blood glucose) 7. HbA1c > 48 mmol/mol and/or fasting plasma glucose > 7 mmol/l within last 12 months |
| Participant exclusion criteria | 1. Current insulin use 2. Recent routine HbA1c on record ≥12% 3. Weight loss of >5kg within the last 6 months 4. Recent eGFR on record <30 mls/min/1.732 5. Substance abuse 6. Known cancer 7. Myocardial infarction within previous 6 months 8. Severe or unstable Heart Failure defined as equivalent to the New York Heart Association (NYHA): Grade 3 - marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or breathlessness, and Grade 4 - unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. or Grade 2 if symptoms are not attributed to obesity - Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or breathlessness 9. Learning difficulties 10. Not fluent in English language 11. Current treatment with anti-obesity drugs 12. Diagnosed eating disorder or purging 13. Pregnant 14. Patients who have required hospitalisation for depression or are on antipsychotic drugs 15. People currently participating in another clinical research trial 16. People with metal implants or devices and those who have claustrophobia cannot take part as MR scans are required as part of the study |
| Recruitment start date | 12/02/2019 |
| Recruitment end date | 30/04/2021 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Glasgow
G31 2ER
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Development Management Office
Clinical Research & Development
West Glasgow Ambulatory Care Hospital
Dalnair Street
Glasgow
G3 8SW
Scotland
United Kingdom
"ROR" |
https://ror.org/05kdz4d87 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/09/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Presentation at scientific conferences. Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 12 | 28/01/2022 | 16/08/2022 | No | No |
| Results article | 01/02/2023 | 14/02/2023 | Yes | No | |
| HRA research summary | 26/07/2023 | No | No |
Additional files
Editorial Notes
14/02/2023: Publication reference and total final enrolment added.
16/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
30/11/2021: The overall trial end date has been changed from 31/12/2021 to 28/02/2022 and the plain English summary has been updated accordingly.
21/04/2021: The target number of participants was changed from 20 to 25.
19/04/2021: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2022 to 31/12/2021.
2. The plain English summary was updated to reflect these changes.
30/03/2021: The following changes were made to the trial record:
1. The overall end date was changed from 30/09/2021 to 31/12/2022.
2. The recruitment end date was changed from 31/03/2021 to 30/04/2021.
3. The plain English summary was updated to reflect these changes.
10/09/2020: Recruitment for this study is no longer paused and the following changes have been made:
1. The recruitment end date has been changed from 31/03/2020 to 31/03/2021.
2. The overall trial end date has been changed from 30/09/2020 to 30/09/2021 and the plain English summary has been updated accordingly.
3. The intention to publish date has been changed from 30/09/2021 to 30/09/2022.
13/07/2020: The trial contact details have been made publicly visible.
12/06/2020: The scientific contact details were changed.
07/04/2020: Due to current public health guidance, recruitment for this study has been paused.
15/01/2020: The following changes have been made:
1. The recruitment start date has been changed from 01/09/2018 to 12/02/2019.
2. The recruitment end date has been changed from 31/12/2019 to 31/03/2020.
3. The overall trial end date has been changed from 30/06/2020 to 30/09/2020.
4. The intention to publish date has been changed from 30/06/2021 to 30/09/2021.
02/04/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2019 to 31/12/2019.
2. The overall trial end date was changed from 30/09/2019 to 30/06/2020.
3. The intention to publish date was changed from 30/09/2020 to 30/06/2021.
19/07/2018: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/10/2017 to 01/09/2018.
2. The recruitment end date was changed from 30/04/2018 to 31/03/2019.
3. The overall trial end date was changed from 31/10/2018 to 30/09/2019.
