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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorHospital Universiti Sains Malaysia

About this trial

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

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Meal replacement therapy

Treatment groups

108 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hospital Universiti Sains Malaysia

Lead sponsor

Ethos Healthcare Sdn Bhd company

Collaborator