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RECRUITING
NCT07270068
NA

Remission of Diabetes With Lifestyle Intervention for Malaysian Patients

Sponsor: Winnie Chee Siew Swee

View on ClinicalTrials.gov

Summary

This study aims to evaluate the effectiveness of structured lifestyle intervention to induce remission of Type 2 Diabetes Mellitus (T2DM) among Malaysian adults. The study will also assess the feasibility of implementing this intervention within Malaysian primary and specialist care settings. The study will also examine the economic impact of the TDR intervention through a cost-effectiveness analysis conducted from a societal perspective. Researchers will compare intensive lifestyle intervention to the usual clinical care. It is hypothesised that Malaysian adults with T2DM who receive the structured lifestyle intervention will demonstrate a significantly higher rate of diabetes remission compared to those receiving usual care. Furthermore, participants in the intervention group are expected to achieve greater mean weight loss, with a higher proportion attaining a sustained weight loss of at least 10 kilograms, relative to the usual care group. The lifestyle intervention is also anticipated to result in superior glycaemic control, as measured by reductions in glycated haemoglobin (HbA1c), and to be more cost-effective in achieving diabetes remission and reducing long-term healthcare utilization.

Official title: Remission of Diabetes With Lifestyle Intervention for Malaysian Type 2 Diabetes Mellitus Patients (ReDiaL-MY) - an Open Label, Randomised Controlled Study

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2025-12-16

Completion Date

2028-04-30

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Total Diet Replacement

Total Diet Replacement (TDR) Phase (8-12weeks), followed by Food reintroduction phase (12-16 weeks) (8 to 12 weeks = 4 months)

BEHAVIORAL

Standard of Care

conventional diet plan and routine physician care

Locations (2)

Klinik Kesihatan Seremban

Seremban, Negeri Sembilam, Malaysia

Hospital Putrajaya

Kuala Lumpur, Putrajaya, Malaysia