Type 2 Diabetes (T2D) Clinical Trials

Find Type 2 Diabetes (T2D) Clinical Trials Near You

Remission of Diabetes With Lifestyle Intervention for Malaysian Type 2 Diabetes Mellitus Patients (ReDiaL-MY) - an Open Label, Randomised Controlled Study

Status: Recruiting

Location: See all (2) locations...

Intervention Type: Behavioral, Dietary supplement

Study Type: Interventional

Study Phase: Not Applicable

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Maximum Age: 70

Healthy Volunteers: f

View:

• 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

Locations

Other Locations

Malaysia

Hospital Putrajaya

RECRUITING

Kuala Lumpur

Klinik Kesihatan Seremban

RECRUITING

Seremban

Contact Information

Primary

Winnie Siew Swee Chee, PhD

Winnie_Chee@imu.edu.my

+6010-3757335

Backup

Yi Qi Cheow, Master

YiQiCheow@imu.edu.my

Time Frame

Start Date: 2025-12-16

Estimated Completion Date: 2028-04-30

Participants

Target number of participants: 92

Treatments

Experimental: Intervention group

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).

Active_comparator: Wait List Control

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.

Related Therapeutic Areas

Obesity

Type 2 Diabetes (T2D)

Similar Clinical Trials

View All