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.
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)
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
Parallel
Meal replacement therapy
Other interventionA serving of Contro Eazy Now is equivalent to 5 scoops (50g) contains 26.5g of carbohydrate, 10g of protein and 8.9g of fat. It supplies 215kcal of energy per serving
To compare changes and differences of HbA1c over a 12-week period in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement vs control group.
The HbA1c test reflects the average blood glucose levels by measuring the percentage of glycated hemoglobin (hemoglobin bound with glucose) and is an important indicator of long term blood sugar control. The HbA1c results are reported as a percentage (%) of glycated hemoglobin. The target HbA1C level for most diabetic individuals is typically below 7% to reduce the risk of diabetes-related complications.
To compare changes and differences in fasting plasma glucose, in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement vs control group.
A fasting blood glucose test measures the amount of glucose in blood after a period of fasting (usually 8-12 hours). Fasting plasma glucose will be measured in millimoles per liter. (mmol/L). The participants fasts overnight, usually for 8 hours before the test.
To compare changes and differences in fasting lipid profile in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement vs control group.
A fasting lipid profile (or lipid panel) measures the levels of various types of fats in the blood, including Total Cholesterol, High-Density Lipoprotein (HDL) Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol and triglycerides. Fasting lipid profile will be measure in millimoles per liter (mmol/L). Patients are usually advised to fast overnight, avoiding food and drinks (except water) for 8 hours before the test.
To compare changes and differences in body mass index (BMI), in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement vs control group.
BMI is a calculated measure of a person's body weight (in kilograms) divided by the square of their height (in meters). BMI is a quick, low-cost, and reliable screening measure for underweight, overweight, or obesity.
To compare changes and differences in body composition (muscle mass(kg), in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement vs control group.
Body composition is the body's amount of fat relative to fat-free mass. It will be measured in kilogram (kg).
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Hospital Universiti Sains Malaysia
Lead sponsor
Ethos Healthcare Sdn Bhd company
Collaborator
