Obesity Type-2 Diabetes Mellitus Obesity Type-2 Diabetes Mellitus Meal Replacement HbA1c
Conditions
Interventions
Participants in meal replacement (MR) group will receive the same diet education as control group (diet consultation group). On top of dietary education, a diabetes-specific meal replacement, Metaboli
Meal Replacement Group,Dietary Consultation Group
Sponsors
Powerlife (M) Sdn. Bhd.
National University of Malaysia Faculty of Medicine Fundamental Grant (GFFP) (Grant number: FF-2023-426)
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with T2DM for at least 6 months with baseline HbA1c levels between 7.5% and 12% for the past three months 2. Overweight or obese with BMI more than or equals to 25kg/m2 3. On stable doses of any oral hypoglycemic agents for the past 3 months
Exclusion criteria
Exclusion criteria: 1. on insulin treatment 2. With chronic kidney disease or on continuous ambulatory peritoneal dialysis or hemodialysis (GFR< 30 ml/min/1.73 m2). 3. With hepatic diseases (ALT > 120 IU/L) 4. With history of chronic alcohol abuse 5. Pregnant and lactating women 6. Currently consuming any weight reduction products or any sliming prescriptions 7. Currently involving in weight loss programs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c Baseline, 12th week, 24th week Automated high performance liquid chromatography analyzer Adams A1c HA-8180V | — |
Secondary
| Measure | Time frame |
|---|---|
| Body Mass Index Baseline, 12th, 24th week Calculation from height and weight.,Body Composition (Muscle mass (kg), fat mass (kg), fat percentage (%) and visceral fat ratings) Baseline, 12th, 24th week measured by using bioelectrical impedance analysis with a body composition analyser (Model; SC-330, TANITA Japan).,Waist and Hip Circumference Baseline, 12th, 24th week Measured by using Lufkin tape.,Fasting blood glucose Baseline, 12th, 24th week Measured using automated photometric analyzer Abott Architect cSystem (Abbott Laboratories, United States) using the hexokinase/Glucose-6-phosphate dehydrogenase (G-6-PDH) method ,Insulin resistance index (HOMA-IR) Baseline, 12th, 24th week Fasting insulin level will be measured using measured using automated chemiluminescent analyzer (Advia Centaur XP Immunoassay System, Siemens, USA). HOMA-IR will be calculated.,Lipid Profile Baseline, 12th, 24th week Total protein, albumin, bilirubin total, ALP, AST will be analyzed using automated photometric analyzer Abott Architect cSystem (Abbott Laboratories, United States).,Satiety level Baseline, 12th, 24th week Visual Analog Scale (VAS) questionnaire will be used to assess the participants perceived satiety after consumption of meal replacement in treatment group or consumption of a meal in control group.,Hormonal Changes Baseline, 12th, 24th week Adiponectin, Leptin, Obestatin and PYY will be measured using Elisa kits.,Quality of Life Baseline, 12th, 24th week Audit of Dependent Diabetes Quality of Life (ADDQOL-19), Diabetes Treatment Satisfaction Questionnaire (DTSQ) and Diabetes Distress Scale (DDS).,Cost Effectiveness Baseline, 12th, 24th week Calculate from QALY obtained from EQ-5D-5L questionnaire.,Body Weight Baseline, 12th, 24th week Weighing scale Tanita HD-309 | — |
Countries
Malaysia
Contacts
Public ContactArimi Fitri Mat Ludin
Universiti Kebangsaan Malaysia
Outcome results
None listed