Meal replacement therapy for better glucose control in type 2 diabetes
The Effect of Meal Replacement Therapy on Glucose Control and Other Metabolic Parameters in Patients With Uncontrolled Type 2 Diabetes on Oral Hypoglycemic Agents: A Randomized Controlled Trial
This study is testing if a meal replacement therapy can help people with uncontrolled type 2 diabetes improve their blood sugar levels and overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | All |
| Sponsor | Hospital Universiti Sains Malaysia Academic / other |
| Locations | 1 site (Kubang Kerian, Kelantan) |
| Trial ID | NCT06862180 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of meal replacement therapy using Contro Eazy NOW on glucose control and metabolic parameters in patients with uncontrolled type 2 diabetes. It is an open-label, prospective, randomized control trial conducted at the Klinik Rawatan Keluarga and diabetes clinic at Hospital Universiti Sains Malaysia. Participants will be monitored over a 12-week period to assess changes in HbA1c, fasting plasma glucose, lipid profiles, body mass index, and overall diabetes quality of life. The study aims to determine the effectiveness of this intervention compared to a control group.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30 to 65 with type 2 diabetes on oral hypoglycemic agents and an HbA1c level between 7-10%.
Not a fit: Patients with severe diabetic complications, advanced liver disease, or those currently involved in weight loss programs may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve glucose control and metabolic health in patients with uncontrolled type 2 diabetes.
How similar studies have performed: Other studies have shown promising results with meal replacement therapies in managing diabetes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients between ≥ 30 to ≤ 65 years old 2. Diagnosed as having type 2 diabetes mellitus base on CPG Malaysia Clinical Practice Guidelines (CPG) for Type 2 Diabetes Mellitus (T2DM) 6th edition 2020. 3. On oral hypoglycaemic agent(s) 4. HbA1c 7- 10 % (result 3 months from the date of recruitment) 5. Agree not to take other beverages, herbal or nutritional supplements for the duration of the study. Exclusion Criteria: 1. Severe diabetic complication(s) including end-stage renal disease and proliferative retinopathy. 2. Pregnancy or plan to get pregnant during the study period 3. Newly diagnosed diabetic less than 3 months from the date of recruitment 4. Currently involve in any weight loss program 5. Currently consuming any meal replacement product 6. Patients with chronic kidney disease with eGFR ≤ 25 ml/min. 7. Patients with advanced liver disease, such as non-alcoholic steatohepatitis (NASH) with significant fibrosis (e.g., liver stiffness measurement \> 9.5 kPa by FibroScan) or cirrhosis. 8. Patients with significantly elevated liver enzymes (e.g., ALT or AST ≥ 3 times the upper limit of normal), which may indicate more severe liver damage.
Where this trial is running
Kubang Kerian, Kelantan
- Hospital Universiti Sains Malaysia — Kubang Kerian, Kelantan, Malaysia (Recruiting)
Study contacts
- Principal investigator: Nani Draman, Masters — Professor
- Study coordinator: kanmani kumaran, MD
- Email: kanmanikumaran@yahoo.com
- Phone: +60135125136
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.