Remission of Diabetes With Lifestyle Intervention for Malaysian Patients

NCT07270068 | Recruiting DMC

• 1 other identifier: ReDiaL-MY
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Type 2 Diabetes; Obesity

Keywords

Type 2 diabetes mellitus; Remission; Malaysia

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving diabetes remission

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

  6 months

Secondary Outcomes (4)

• Proportion of patients maintaining diabetes remission

  12 months

• Weight loss

  3 months, 6 months and 12 months

• Insulin Resistance (HOMA-IR)

  3 months, 6 months and 12 months

• Pancreatic β-cell function (HOMA-β)

  3 months, 6 months and 12 months

Other Outcomes (5)

• Physical Functions

  3 months, 6 months and 12 months

• Muscle Strength

  3 months, 6 months and 12 months

• Cost-effectiveness

  6 months and 12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

The Intervention group will undergo total diet replacement (TDR) phase for 8-12 weeks of followed by food reintroduction (12-16 weeks). After the RCT phase (up to 16 weeks), the intervention group enters a weight maintenance period for 24 weeks. The participant will be given 4 servings Diabetes-specific formula (DSF) of Glucerna® Control Vanilla Flavour or 3 servings of DSF with additional \~300 kcal low calorie low glycaemic index portion-controlled meal for daily consumption within a minimum of 8 weeks to a maximum of 12 weeks during the TDR phase. In the food reintroduction phase, there will be a gradual replacement of the DSF with low calorie low glycemic index portion-controlled meals. While in the weight maintenance phase, participants will be offered the use of 1 DSF a day as part of their healthy diet plan (1200 - 1500 kcal/day).

Dietary Supplement: Total Diet Replacement

Wait List Control

ACTIVE COMPARATOR

The wait-list control group will follow the usual care consisting of conventional diet plan and routine physician care for the initial 24 weeks of intervention parallel to the Intervention group. Upon completion of the 24 weeks of the intervention group, the wait-list control group will crossover to receive the similar intervention and observation plans as per the intervention group.

Behavioral: Standard of Care

Interventions

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)

Intervention group

Standard of Care BEHAVIORAL

conventional diet plan and routine physician care

Wait List Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Type 1 DM
• 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
• 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

Sponsors & Collaborators

• Winnie Chee Siew Swee: lead
• Ministry of Health, Malaysia: collaborator

Study Sites (2)

Klinik Kesihatan Seremban

Seremban, Negeri Sembilam, 70300, Malaysia

RECRUITING

Hospital Putrajaya

Kuala Lumpur, Putrajaya, 62250, Malaysia

RECRUITING

Related Publications (3)

• Taylor R. Aetiology of type 2 diabetes: an experimental medicine odyssey. Diabetologia. 2025 Jul;68(7):1375-1389. doi: 10.1007/s00125-025-06428-0. Epub 2025 May 2.

  PMID: 40316731 BACKGROUND

• Sattar N, Welsh P, Leslie WS, Thom G, McCombie L, Brosnahan N, Richardson J, Gill JMR, Crawford L, Lean MEJ. Dietary weight-management for type 2 diabetes remissions in South Asians: the South Asian diabetes remission randomised trial for proof-of-concept and feasibility (STANDby). Lancet Reg Health Southeast Asia. 2023 Feb;9:100111. doi: 10.1016/j.lansea.2022.100111.

  BACKGROUND

• Lean MEJ, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Welsh P, Kean S, Ford I, McConnachie A, Messow CM, Sattar N, Taylor R. Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial. Lancet Diabetes Endocrinol. 2019 May;7(5):344-355. doi: 10.1016/S2213-8587(19)30068-3. Epub 2019 Mar 6.

  PMID: 30852132 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Winnie Siew Swee Chee, PhD

  IMU University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Winnie Siew Swee Chee, PhD

CONTACT

+6010-3757335; Winnie_Chee@imu.edu.my

Yi Qi Cheow, Master

CONTACT

YiQiCheow@imu.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Institute for Research, Development and Innovation (IRDI)

Model Details: This is a randomised wait-list-controlled trial, that consists of : i) a randomised clinical trial phase (6 months) and ii) an observational follow-up phase (6 months) Participants will be randomised either to commence the intervention immediately after randomisation (intervention group), or to continue usual management of T2DM for six months, prior to starting the intervention (wait-list control group). Thereafter, the intervention group would enter the weight maintenance phase for another 6 months. The wait-list control would be offered the intervention for 6 months and follow-up on the weight maintenance, similar to the intervention group. This study design will provide comparisons between groups during the randomised phase of 6 months, and observational data in an enlarged cohort (wait-list control + intervention) on weight maintenance phase for and additional 6 month.

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 8, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2)