Lifestyle program to try to put Type 2 diabetes into remission for Malaysian adults

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

This program tests whether a structured diet and weight‑loss plan can put Malaysian adults with recently diagnosed type 2 diabetes into remission compared with usual care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: IMU University, Malaysia (other)
• Locations: 2 sites (Seremban, Negeri Sembilam and 1 other locations)
• Trial ID: NCT07270068 on ClinicalTrials.gov

What this trial studies

This is a randomized, wait‑list–controlled, dual‑phase trial comparing an intensive lifestyle intervention (including a total diet replacement phase) to standard clinical care in Malaysian primary and specialist settings. Eligible participants are adults with type 2 diabetes diagnosed under 3 years, BMI over 25 kg/m2, HbA1c 6.5–9%, and treated with oral glucose‑lowering drugs but not insulin. The trial will measure diabetes remission rates and sustained weight loss, and include a cost‑effectiveness analysis from a societal perspective. The protocol tests feasibility, acceptability, and economic impact of translating intensive remission approaches into routine Malaysian care.

Who should consider this trial

Good fit: Malaysian adults with type 2 diabetes diagnosed less than 3 years, BMI >25 kg/m2, recent HbA1c 6.5–9%, and currently treated with one or more oral glucose‑lowering drugs (not on insulin).

Not a fit: People with type 1 diabetes, those using basal or multiple daily insulin injections, recent routine HbA1c >9%, recent large weight loss, recent weight‑loss medications, prior bariatric or major bowel surgery, substance abuse, or severe uncontrolled comorbidities may not benefit or be eligible.

Why it matters

Potential benefit: If successful, the program could help people with early type 2 diabetes in Malaysia achieve remission, lose substantial weight, and reduce medication needs and long‑term complications.

How similar studies have performed: Previous intensive weight‑loss programs such as the DiRECT trial in the UK have produced high remission rates, but their transferability to Malaysian primary care remains to be shown.

Eligibility criteria

Inclusion Criteria:

1. Diagnosed diabetes for a duration of \< 3 years (diagnosis based on 2 recorded diagnostic-level tests, HbA1C and/or blood glucose)
2. Body mass index (BMI) \> 25 kg/m2
3. HbA1C level above \> 6.5% to 9% as per the last routine clinical check within 6 months
4. Currently being treated with one or more oral glucose lowering drugs

Exclusion Criteria:

1. Type 1 DM
2. Type 2 DM on basal or multiple insulin injections
3. Recent routine HbA1C of \> 9%
4. Patients who in the past 6 months have weight loss exceeding 5 kg (such individuals may have difficulty losing additional weight)
5. Recent (last 12 weeks) or current use of medications/meal replacements for weight loss
6. Alcoholism or any substance abuse
7. History of bariatric surgery, small bowel resection, or extensive bowel resection
8. Chronic treatment with systemic corticosteroids. Use of hormone replacement therapy or oral contraceptives will not lead to exclusion
9. Severe hypertension on multiple drugs treatment
10. Currently pregnant or nursing and planning to get pregnant
11. Requiring hospitalization for depression or are on antipsychotic medications
12. Cancer requiring treatment for the past 5 years, except of non-melanoma skin cancers or cancers that have been clearly cured
13. HIV- positive (self-report) due to effects or weight and body composition of HIV and medications treating HIV
14. 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)
15. Renal disease - eGFR \< 60 ml/min (based MDRD) or currently receiving dialysis
16. Proliferative retinopathy and other severe diabetes complications
17. Diagnosed eating disorder or purging

Where this trial is running

Seremban, Negeri Sembilam and 1 other locations

• Klinik Kesihatan Seremban — Seremban, Negeri Sembilam, Malaysia (RECRUITING)
• Hospital Putrajaya — Kuala Lumpur, Putrajaya, Malaysia (RECRUITING)

Study contacts

• Principal investigator: Winnie Siew Swee Chee, PhD — IMU University
• Study coordinator: Winnie Siew Swee Chee, PhD

Conditions: Type 2 Diabetes, Obesity, Type 2 diabetes mellitus, Remission, Malaysia