Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT07270068

Remission of Diabetes With Lifestyle Intervention for Malaysian Patients

Led by Winnie Chee Siew Swee · Updated on 2026-03-27

92

Participants Needed

2

Research Sites

123 weeks

Total Duration

On this page

Sponsors

W

Winnie Chee Siew Swee

Lead Sponsor

M

Ministry of Health, Malaysia

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Remission of Diabetes With Lifestyle Intervention for Malaysian Patients

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed diabetes for less than 3 years based on recorded HbA1c and/or blood glucose tests
  • Body mass index (BMI) greater than 25 kg/m2
  • HbA1c level between above 6.5% and 9% within the last 6 months
  • Currently treated with one or more oral glucose-lowering drugs
Not Eligible

You will not qualify if you...

  • Type 1 diabetes mellitus
  • Type 2 diabetes treated with basal or multiple insulin injections
  • Recent HbA1c above 9%
  • Weight loss exceeding 5 kg in the past 6 months
  • Use of medications or meal replacements for weight loss in the past 12 weeks
  • Alcoholism or substance abuse
  • History of bariatric or extensive bowel surgery
  • Chronic systemic corticosteroid treatment
  • Severe hypertension requiring multiple drugs
  • Currently pregnant, nursing, or planning pregnancy
  • Hospitalization for depression or use of antipsychotic medications
  • Cancer treatment in the past 5 years except non-melanoma skin cancers or cured cancers
  • HIV-positive status
  • Recent cardiovascular events or rehabilitation within specified time frames
  • Renal disease with eGFR below 60 ml/min or on dialysis
  • Severe diabetes complications such as proliferative retinopathy
  • Diagnosed eating disorder or purging behavior

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Klinik Kesihatan Seremban

Seremban, Negeri Sembilam, Malaysia, 70300

Actively Recruiting

2

Hospital Putrajaya

Kuala Lumpur, Putrajaya, Malaysia, 62250

Actively Recruiting

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Research Team

W

Winnie Siew Swee Chee, PhD

CONTACT

Y

Yi Qi Cheow, Master

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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