Clinical trial

Remission of Diabetes With Lifestyle Intervention for Malaysian Patients

Recruiting now · Not applicable · 1 countries · Registry ID NCT07270068

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionType 2 Diabetes, Obesity

Full registry 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

Treatments and study arms

Total Diet Replacement

Dietary Supplement

Total Diet Replacement (TDR) Phase (8-12weeks), followed by Food reintroduction phase (12-16 weeks) (8 to 12 weeks = 4 months)

Standard of Care

Behavioral

conventional diet plan and routine physician care

Primary outcomes

Proportion of patients achieving diabetes remission6 months

Diabetes remission defined as HbA1C ≤ 6.5% or ≤48 mmol/mol and no diabetes medication required.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Hospital Putrajaya🇲🇾 Kuala Lumpur, Putrajaya, Malaysia

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Zanariah Hussein, MedicineContact

Zanariah Hussein, MedicinePrincipal Investigator

Klinik Kesihatan Seremban🇲🇾 Seremban, Negeri Sembilam, Malaysia

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Nazihah Rejab, MedicineContact

Nazihah Rejab, MedicinePrincipal Investigator