Recruiting

Effect of Meal Replacement Therapy on Glucose Control and Metabolic Parameters in Patients With Uncontrolled Diabetes

To evaluate the effect of meal replacement therapy on glucose control and other metabolic parameters in patients with uncontrolled type 2 diabetes. Methodology: This is an open-label, prospective, randomized control trial study. Study duration. August 2023 - March 2026. Study location. This study will be conducted at the Klinik Rawatan Keluarga and diabetes clinic Hospital Universiti Sains Malaysia. Source Reference : People with type 2 diabetes mellitus attending the Hospital Universiti Sains Malaysia. Study…

ClinicalTrials.gov IDNCT06862180

PhaseNA

Enrollment108

SponsorHospital Universiti Sains Malaysia

Age30 Years

SexALL

I'm interested View official listing

Conditions studied

Diabetes Mellitus, Type 2

About this study

Interventions

Other: Meal replacement therapy — A serving of Contro Eazy Now is equivalent to 5 scoops (50g) contains 26.5g of carbohydrate, 10g of protein and 8.9g of fat. It supplies 215kcal of energy per serving

Primary outcomes

To compare changes and differences of HbA1c over a 12-week period in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement vs control group. (12 weeks)

Eligibility information

Inclusion Criteria: 1. Patients between ≥ 30 to ≤ 65 years old 2. Diagnosed as having type 2 diabetes mellitus base on CPG Malaysia Clinical Practice Guidelines (CPG) for Type 2 Diabetes Mellitus (T2DM) 6th edition 2020. 3. On oral hypoglycaemic agent(s) 4. HbA1c 7- 10 % (result 3 months from the date of recruitment) 5. Agree not to take other beverages, herbal or nutritional supplements for the duration of the study. Exclusion Criteria: 1. Severe diabetic complication(s) including end-stage renal disease and proliferative retinopathy. 2. Pregnancy or plan to get pregnant during the study period 3. Newly diagnosed diabetic less than 3 months from the date of recruitment 4. Currently involve in any weight loss program 5. Currently consuming any meal replacement product 6. Patients with chronic kidney disease with eGFR ≤ 25 ml/min. 7. Patients with advanced liver disease, such as non-alcoholic steatohepatitis (NASH) with significant fibrosis (e.g., liver stiffness measurement \> 9.5 kPa by FibroScan) or cirrhosis. 8. Patients with significantly elevated liver enzymes (e.g., ALT or AST ≥ 3 times the upper limit of normal), which may indicate more severe liver damage.

Study locations

Hospital Universiti Sains Malaysia, Kubang Kerian, Kelantan 16150 Malaysia

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.