Meal replacement therapy for better glucose control in type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.