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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: Winnie_Chee@imu.edu.my
• Phone: +6010-3757335

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Switching to Zenagamtide From Tirzepatide in Adults With Overweight or Obesity With or Without Type 2 Diabetes

  This study tests whether adults who are overweight or have obesity (with or without type 2 diabetes) can switch from tirzepatide to a new treatment called zenagamtide to find a tolerable dose.

  Recruiting at 2 sites Phase 1 Novo Nordisk A/S · Glendale, California and 1 other locations · NCT07868354

• Switching to Zenagamtide from Semaglutide in adults with overweight or obesity, with or without type 2 diabetes

  This study tests whether adults who are already taking semaglutide can successfully switch to zenagamtide at different doses to see which dose works best.

  Recruiting at 2 sites Phase 1 Novo Nordisk A/S · Glendale, California and 1 other locations · NCT07855133

• Using Multimodal Ultrasound to Check Muscle Mass in Metabolic Disease Patients

  This study tests whether a multimodal ultrasound approach can accurately measure muscle mass in people with metabolic syndrome, obesity, sarcopenia, or type 2 diabetes.

  Recruiting Zhangzhou Municipal Hospital · Zhangzhou, Fujian · NCT07836088

• GUB-UCN2 in healthy, obese, and T2D adults: a first-in-human safety and pharmacology study

  This study tests GUB-UCN2 to see if it is safe and tolerable and how it behaves in the body in healthy adults, people with obesity, and people with obesity with or without type 2 diabetes.

  Recruiting Phase 1/2 Gubra A/S · Neuss · NCT07702890

• Two doses of CagriSema plus one dose of Semaglutide for weight loss in obesity with or without type 2 diabetes

  This study tests whether two doses of CagriSema, plus a dose of Semaglutide, help adults with obesity (with or without type 2 diabetes) lose weight.

  Recruiting Phase 3 Novo Nordisk A/S · Birmingham, Alabama and 302 other locations · NCT07564414

• Semaglutide's effects on heart and muscle mass

  This project will use MRI scans and strength tests over 12 months to see if semaglutide changes body and heart muscle in adults starting the medication.

  Recruiting University of Alberta · Edmonton, Alberta · NCT07272837

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.