Testing a traditional food-based intervention for weight loss and type 2 diabetes remission
| ISRCTN | ISRCTN10671396 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10671396 |
- Submission date
- 10/09/2023
- Registration date
- 13/09/2023
- Last edited
- 10/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
This study will evaluate a low-cost, easily accessible food-based treatment for type 2 diabetes in overweight patients. The diet treatment uses only traditional local Nepali foods, designed to provide all the essential vitamins and minerals, in amounts to cause a weight loss of 10 kg in 8 weeks, if it is followed carefully.
Who can participate?
People living in Kathmandu, aged 30-70 years, with type 2 diabetes up to 5 years after diagnosis, not on high-dose insulin treatment, who are overweight.
What does the study involve?
The researchers will assess how many people are able to follow the diet plan to achieve remission of their diabetes (their blood tests show they no longer have diabetes, while off anti-diabetes medications for at least 2 months).
What are the possible benefits and risks of participating?
There may be other benefits from weight loss, including better blood pressure control, and improved quality of life. There are no important hazards or risks from participation, but diet control is always hard and requires commitment.
Where is the study run from?
Metro Hospital (Kathmandu)
When is the study starting and how long is it expected to run for?
September 2020 to December 2023
Who is funding the study?
All Saints Educational Trust (UK)
Who is the main contact?
Prof. Michael Lean, mike.lean@glasgow.ac.uk
Contact information
Principal Investigator
Human Nutrition
University of Glasgow
New Lister Building
Glasgow Royal Infirmary
Glasgow
G31 2ER
United Kingdom
 ORCID ID |
0000-0003-2216-0083 |
|---|---|
| Phone | +44 (0)7720885387 |
| mike.lean@glasgow.ac.uk |
Study information
| Study design | Single-centre pragmatic single-arm evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Efficacy |
| Participant information sheet | Not applicable (low literacy population) |
| Scientific title | Hospital-based Diabetes Remission Clinical Trial in Nepal (Ho-DiRECT-Nepal): a food-based educational and home-economics intervention for type 2 diabetes remission |
| Study acronym | Ho-DiRECT-NEPAL |
| Study objectives | A diet intervention, based on the UK Diabetes Remission Clinical Trial (DiRECT), but using only low-cost traditional foods, will generate significant weight losses from baseline, and remissions of recent-onset type 2 diabetes, in people attending hospital-based diabetes clinics in Kathmandu, Nepal |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | Opinions were sought from the Nepal Health Research Council (NHRC) and Kathmandu University Institutional Review Committee (IRC), who concluded that with no randomisation, and with no new experimental intervention, this study would be considered a service evaluation, which does not require ethical approval. |
| Health condition(s) or problem(s) studied | Remission of type 2 diabetes in overweight patients |
| Intervention | Patients aged 30-70 years attending hospital diabetes clinics who have had type 2 diabetes up to 5 years, and with Body Mass Index above 23 kg/m² will be invited to participate. Participants will be educated about T2D and its multimorbid complications and offered a dietary intervention program. The health workers and nutritionists will contact the participants to provide support twice weekly up to week 10, and then 4-weekly. Anthropometric measurements and biochemistry will be conducted routinely. Weight-control support will continue irrespective of T2D remission, aiming to limit related multimorbid conditions. Patient recruitment and dietary intervention will be conducted within the care of diabetes specialists and nutritionists/dieticians. The dietary program: 1. A Total Diet Replacement (TDR) Phase for weight loss induction, which will last for the first 8 weeks, using only low-cost traditional foods, similar to the Scottish ‘No Doubts Diet’ based on porridge and lentil soups 2. Reintroduction of meals, again using only low-cost traditional foods, for weight loss maintenance |
| Intervention type | Behavioural |
| Primary outcome measure | Remission of type 2 diabetes (HbA1c <48 mmol/mol [<6.5%]) after 6 months |
| Secondary outcome measures | 1. Body weight measured with scales at 3, 6 and 12 months 2. HbA1c measured by standard laboratory method at 6 and 12 months 3. Blood pressure measured by electronic sphygmomanometer at 6 and 12 months 4. Microalbuminuria measured by dipstick and standard laboratory method at 6 and 12 months 5. Liver function tests measured by standard laboratory method at 6 and 12 months 6. Ultrasound liver fat measured at 6 and 12 months (if available) 7. Quality of life measured using WHO-BREF – QoL (Nepali version) at 6 and 12 months 8. Glucose-lowering and antihypertensive medications prescribed at 3, 6 and 12 months 9. Participant experience measured by qualitative interviews in a subset at different study stages |
| Overall study start date | 01/09/2020 |
| Completion date | 01/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 30 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 80 |
| Total final enrolment | 85 |
| Key inclusion criteria | 1. Age 30-70 years 2. Men and women 3. Type 2 diabetes of duration up to 4 years since diagnosis 4. Not insulin-dependent/type 1 diabetes 5. Body mass index >23 kg/m² |
| Key exclusion criteria | 1. Weight loss of >5 kg within the last 6 months 2. Pregnancy/lactation 3. MI or stroke in the past 3 months 4. Chronic pancreatitis, alcohol dependence, psychiatric illness and learning disability 5. Patients using insulin more than 30 units basal, or other complex insulin regimen |
| Date of first enrolment | 29/03/2022 |
| Date of final enrolment | 19/09/2022 |
Locations
Countries of recruitment
- Nepal
Study participating centre
P8RQ+42C, Kathmandu 44600
Nepal
Sponsor information
Hospital/treatment centre
Dhulikhel
Dhulikhel
45200
Nepal
| Phone | +977 (0)11 490497 |
|---|---|
| birajmk@kusms.edu.np | |
| Website | http://www.kmc.edu.np/ |
"ROR" |
https://ror.org/00tcmr651 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/11/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal, and presentations at scientific and professional meetings in Nepal and internationally. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Prof. Mike Lean (mike.lea@glasgow.ac.uk). Data will be anonymised and provided to researchers for any reasonable scientific purpose for at least 10 years. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 13/09/2023 | No | No | ||
| Results article | 17/08/2024 | 10/09/2024 | Yes | No |
Additional files
Editorial Notes
10/09/2024: Publication reference added.
13/09/2023: Study's existence confirmed by the All Saints Educational Trust.
