Efficacy and Sustainability of Diabetes Specific Formula (Metabolic Sauver) on Weight Reduction and Glycaemic Control among Overweight and Obese Patients with Type-2 Diabetes Mellitus
Phase 1
- Conditions
- ObesityType-2 Diabetes MellitusObesityType-2 Diabetes MellitusMeal ReplacementHbA1c
- Registration Number
- TCTR20210921004
- Lead Sponsor
- Powerlife (M) Sdn. Bhd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 156
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
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
8. Diagnosed with COVID-19
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c Baseline, 12th week, 48th week Automated high performance liquid chromatography analyzer Adams A1c HA-8180V,Body Weight Baseline, 6th, 12th, 24th, 36th and 48th week Weighing scale Tanita HD-309
- Secondary Outcome Measures
Name Time Method