Effect of Meal Replacement Therapy on Glucose Control and Metabolic Parameters in Patients With Uncontrolled Diabetes
Recruiting · NCT06862180 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital Universiti Sains Malaysia
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 source population : People with type 2 diabetes mellitus attended Klinik Rawatan Keluarga and diabetes clinic Hospital Universiti Sains Malaysia during the study period.
Who can take part
Inclusion criteria
- Patients between ≥ 30 to ≤ 65 years old
- Diagnosed as having type 2 diabetes mellitus base on CPG Malaysia Clinical Practice Guidelines (CPG) for Type 2 Diabetes Mellitus (T2DM) 6th edition 2020.
- On oral hypoglycaemic agent(s)
- HbA1c 7- 10 % (result 3 months from the date of recruitment)
- Agree not to take other beverages, herbal or nutritional supplements for the duration of the study.
Exclusion criteria
- Severe diabetic complication(s) including end-stage renal disease and proliferative retinopathy.
- Pregnancy or plan to get pregnant during the study period
- Newly diagnosed diabetic less than 3 months from the date of recruitment
- Currently involve in any weight loss program
- Currently consuming any meal replacement product
- Patients with chronic kidney disease with eGFR ≤ 25 ml/min.
- 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.
- 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.
Where it is running
1 location listed.
- Hospital Universiti Sains Malaysia - Kubang Kerian, Kelantan, Malaysia