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

Summary

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.

Eligibility

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.

Conditions2

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