NCT07270068Recruiting
Remission of Diabetes With Lifestyle Intervention for Malaysian Patients
Remission of Diabetes With Lifestyle Intervention for Malaysian Type 2 Diabetes Mellitus Patients (ReDiaL-MY) - an Open Label, Randomised Controlled Study
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 92 (estimated)
- First submitted
- 21 Nov 2025
- Start date
- 16 Dec 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Winnie Chee Siew Swee
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07270068
What you commit to
- Study type: Interventional
- Planned participants: 92
- From 16 Dec 2025 to the primary completion date, 31 Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent (last 12 weeks) or current use of medications/meal replacements for weight loss
- Chronic treatment with systemic corticosteroids. Use of hormone replacement therapy or oral contraceptives will not lead to exclusion
- Requiring hospitalization for depression or are on antipsychotic medications
Other illness
- History of bariatric surgery, small bowel resection, or extensive bowel resection
- Severe hypertension on multiple drugs treatment
- Cancer requiring treatment for the past 5 years, except of non-melanoma skin cancers or cancers that have been clearly cured
- HIV- positive (self-report) due to effects or weight and body composition of HIV and medications treating HIV
- Cardiovascular disease (heart attack or procedure within past 3 months or participation in cardiac rehabilitation program within last 3 months, stroke or history/ treatment for transient ischemic attacks in the past 3 months, or documented history of pulmonary embolus for the past 6 months)
- Proliferative retinopathy and other severe diabetes complications
- Diagnosed eating disorder or purging
Lab values
- Recent routine HbA1C of \> 9%
- Renal disease - eGFR \< 60 ml/min (based MDRD) or currently receiving dialysis
Other
- Type 1 DM
- Type 2 DM on basal or multiple insulin injections
- Patients who in the past 6 months have weight loss exceeding 5 kg (such individuals may have difficulty losing additional weight)
- Alcoholism or any substance abuse
- Currently pregnant or nursing and planning to get pregnant
Who the study is looking for
- Diagnosed diabetes for a duration of \< 3 years (diagnosis based on 2 recorded diagnostic-level tests, HbA1C and/or blood glucose)
- Body mass index (BMI) \> 25 kg/m2
- HbA1C level above \> 6.5% to 9% as per the last routine clinical check within 6 months
- Currently being treated with one or more oral glucose lowering drugs
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Putrajaya Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Recruiting |
| Klinik Kesihatan Seremban Coordinator of this site? Confirm its status | Seremban | Malaysia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.