Actively Recruiting
Effect of Meal Replacement Therapy on Glucose Control and Metabolic Parameters in Patients With Uncontrolled Diabetes
Led by Hospital Universiti Sains Malaysia · Updated on 2025-03-06
108
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
Sponsors
H
Hospital Universiti Sains Malaysia
Lead Sponsor
E
Ethos Healthcare Sdn Bhd company
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Meal Replacement Therapy on Glucose Control and Metabolic Parameters in Patients With Uncontrolled Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients between 30 to 65 years old
- Diagnosed with type 2 diabetes mellitus based on Malaysia Clinical Practice Guidelines
- Currently taking oral hypoglycemic agents
- HbA1c between 7% and 10% within 3 months of recruitment
- Agree not to consume other beverages, herbal, or nutritional supplements during the study
You will not qualify if you...
- Severe diabetic complications such as end-stage renal disease or proliferative retinopathy
- Pregnancy or plans to become pregnant during the study
- Diagnosed with diabetes less than 3 months before recruitment
- Currently participating in any weight loss program
- Currently consuming any meal replacement products
- Chronic kidney disease with eGFR 25 ml/min or less
- Advanced liver disease including non-alcoholic steatohepatitis with significant fibrosis or cirrhosis
- Significantly elevated liver enzymes (ALT or AST 3 times or more above normal limits)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, Malaysia, 16150
Actively Recruiting
Research Team
K
kanmani kumaran, MD
CONTACT
N
Nani Draman, Masters
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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