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Testing a traditional food-based intervention for weight loss and type 2 diabetes remission

Hospital-based Diabetes Remission Clinical Trial in Nepal (Ho-DiRECT-Nepal): a food-based educational and home-economics intervention for type 2 diabetes remission

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10671396
Enrollment
80
Registered
2023-09-13
Start date
2022-03-29
Completion date
Unknown
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Remission of type 2 diabetes in overweight patients Nutritional, Metabolic, Endocrine

Interventions

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 e

Sponsors

Kathmandu Medical College Teaching Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Remission of type 2 diabetes (HbA1c <48 mmol/mol [<6.5%]) after 6 months

Secondary

MeasureTime frame
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

Countries

Nepal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 6, 2026