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Recruiting NCT06862180

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

Trial Parameters

Condition Diabetes Mellitus, Type 2
Sponsor Hospital Universiti Sains Malaysia
Study Type INTERVENTIONAL
Phase N/A
Enrollment 108
Sex ALL
Min Age 30 Years
Max Age 65 Years
Start Date 2024-11-01
Completion 2025-05
Interventions
Meal replacement therapy

Brief 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 Criteria

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

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