NCT06862180Recruiting
Effect of Meal Replacement Therapy on Glucose Control and Metabolic Parameters in Patients With Uncontrolled 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
Source: ClinicalTrials.gov · Last updated 6 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- First submitted
- 18 Jan 2025
- Start date
- 1 Nov 2024
- Primary completion date
- May 2025
- Lead sponsor
- Hospital Universiti Sains Malaysia
- Diseases
- Type 2 diabetes
- NCT number
- NCT06862180
What you commit to
- Study type: Interventional
- Planned participants: 108
- From 1 Nov 2024 to the primary completion date, May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe diabetic complication(s) including end-stage renal disease and proliferative retinopathy.
- 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.
Lab values
- Patients with chronic kidney disease with eGFR ≤ 25 ml/min.
- 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.
Other
- Pregnancy or plan to get pregnant during the study period
- Newly diagnosed diabetic less than 3 months from the date of recruitment
- Currently involve in any weight loss program
- Currently consuming any meal replacement product
Who the study is looking for
- Patients between ≥ 30 to ≤ 65 years old
- Diagnosed as having type 2 diabetes mellitus base on CPG Malaysia Clinical Practice Guidelines (CPG) for Type 2 Diabetes Mellitus (T2DM) 6th edition 2020.
- On oral hypoglycaemic agent(s)
- HbA1c 7- 10 % (result 3 months from the date of recruitment)
- Agree not to take other beverages, herbal or nutritional supplements for the duration of the study.
Age in the registry: 30 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universiti Sains Malaysia Coordinator of this site? Confirm its status | Kubang Kerian | Malaysia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.