RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

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

Locations (2)

Klinik Kesihatan Seremban

Seremban, Negeri Sembilam, Malaysia

Hospital Putrajaya

Kuala Lumpur, Putrajaya, Malaysia