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

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About this study

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.

Condition
Diabetes Mellitus, Type 2
Tested
Meal replacement therapy
Sponsor
Hospital Universiti Sains Malaysia

Who can join

Age
30 to 65 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 8

  • Minimum age: 30 years
  • Maximum age: 65 years
  • Study condition: Diabetes Mellitus, Type 2
  • 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 8

  • 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

1 site, 1 recruiting

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, Malaysia

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.