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Remission of Diabetes With Lifestyle Intervention for Malaysian Patients

NCT07270068 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Ministry of Health, Malaysia

    collaborator OTHER_GOV

  • Winnie Chee Siew Swee

    lead OTHER

Principal Investigators

  • Winnie Siew Swee Chee, PhD · IMU University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-16
Primary Completion
2027-12-31
Completion
2028-04-30

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07270068 on ClinicalTrials.gov