Remission of Diabetes With Lifestyle Intervention for Malaysian Type 2 Diabetes Mellitus Patients (ReDiaL-MY) - an Open Label, Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 3
- 主要终点
- Proportion of patients achieving diabetes remission
研究概览
简要总结
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.
详细描述
Malaysia is facing an epidemic of diabetes and despite public health efforts to increase awareness, screening and prevention, there is a continued rise in the prevalence of diabetes and its complications. A lifestyle approach for diabetes remission may be a solution to curb further rise in diabetes complications and be cost-effective.
Little is known about the transferability of diabetes remission lifestyle intervention into Malaysian primary care settings. This knowledge is important to understand whether DiRECT is feasible, actionable and acceptable to patients, clinicians and primary care settings given the original trial was developed overseas. Furthermore, local data on the economic burden of diabetes and the potential savings from remission are urgently needed to support evidence-based policymaking. This study will therefore include an economic evaluation using a cost-of-illness approach with a prevalence-based model, incorporating both direct and indirect costs from the societal perspective. In addition, the results from this proposed study will be important to see how we can increase acceptability of this approach in Malaysia and curb a disabling disease that is rapidly rising in Malaysia.
This study is a randomised, wait-list-controlled, dual-phase trial designed to evaluate the efficacy and cost-effectiveness of a structured lifestyle intervention for inducing remission of Type 2 Diabetes Mellitus (T2DM) in Malaysian adults. The protocol integrates a rigorous clinical trial framework with a comprehensive economic evaluation from a societal perspective.
The trial employs a randomised wait-list-controlled design, comprising two distinct phases:
- Randomised Controlled Trial (RCT) Phase: Eligible participants are randomised in a 1:1 ratio, using a computer-generated sequence via an online software (Sealed Envelope), to either the immediate intervention group or a wait-list control group. The structured intervention is undergo 12 weeks of total diet replacement course, followed by food reintroduction (12 weeks). The wait-list group will receive standard of care for the primary endpoint assessment at 24 weeks.
- Observational Follow-up Phase: Following the RCT phase, the intervention group enters a weight maintenance period. The wait-list control group crosses over to receive the identical structured intervention for 24 weeks. This phase provides longitudinal data on weight maintenance and diabetes remission sustainability in an enlarged cohort for up to 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Type 2 DM on basal or multiple insulin injections
- •Recent routine HbA1C of > 9%
- •Patients who in the past 6 months have weight loss exceeding 5 kg (such individuals may have difficulty losing additional weight)
- •Recent (last 12 weeks) or current use of medications/meal replacements for weight loss
- •Alcoholism or any substance abuse
- •History of bariatric surgery, small bowel resection, or extensive bowel resection
- •Chronic treatment with systemic corticosteroids. Use of hormone replacement therapy or oral contraceptives will not lead to exclusion
- •Severe hypertension on multiple drugs treatment
- •Currently pregnant or nursing and planning to get pregnant
- •Requiring hospitalization for depression or are on antipsychotic medications
- •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)
- •Renal disease - eGFR < 60 ml/min (based MDRD) or currently receiving dialysis
- •Proliferative retinopathy and other severe diabetes complications
- •Diagnosed eating disorder or purging
结局指标
主要结局
Proportion of patients achieving diabetes remission
时间窗: 6 months
Diabetes remission defined as HbA1C ≤ 6.5% or ≤48 mmol/mol and no diabetes medication required.
次要结局
- Proportion of patients maintaining diabetes remission(12 months)
- Weight loss(12 weeks, 6 months and 12 months)
- Insulin Resistance (HOMA-IR)(12 weeks, 6 months and 12 months)
- Pancreatic β-cell function (HOMA-β)(12 weeks, 6 months and 12 months)
研究者
Winnie Chee Siew Swee
Director of Institute for Research, Development and Innovation (IRDI)
IMU University