Effect of Meal Replacement Therapy on Glucose Control and Metabolic Parameters in Patients With Uncontrolled Diabetes

NCT06862180 | Recruiting DMC

• 1 other identifier: RSCH ID-23-06002-VHE.
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• To compare changes and differences of HbA1c over a 12-week period in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement vs control group.

  The HbA1c test reflects the average blood glucose levels by measuring the percentage of glycated hemoglobin (hemoglobin bound with glucose) and is an important indicator of long term blood sugar control. The HbA1c results are reported as a percentage (%) of glycated hemoglobin. The target HbA1C level for most diabetic individuals is typically below 7% to reduce the risk of diabetes-related complications.

  12 weeks

Secondary Outcomes (12)

• To compare changes and differences in fasting plasma glucose, in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement vs control group.

  12 weeks

• To compare changes and differences in fasting lipid profile in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement vs control group.

  12 weeks

• To compare changes and differences in body mass index (BMI), in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement vs control group.

  12 weeks.

• To compare changes and differences in body composition (muscle mass(kg), in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement vs control group.

  12 weeks

• To compare changes and differences in diabetes quality of life in patients with type 2 diabetes mellitus in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents on meal replacement vs control group.

  12 weeks.

Study Arms (2)

Intervention group

EXPERIMENTAL

Meal replacement therapy .

Other: Meal replacement therapy

Control group

NO INTERVENTION

Dietary consultation.

Interventions

Meal replacement therapy OTHER

A serving of Contro Eazy Now is equivalent to 5 scoops (50g) contains 26.5g of carbohydrate, 10g of protein and 8.9g of fat. It supplies 215kcal of energy per serving

Also known as: Contro Eazy Now.

Intervention group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Severe diabetic complication(s) including end-stage renal disease and proliferative retinopathy.
• 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
• Patients with chronic kidney disease with eGFR ≤ 25 ml/min.
• 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.
• 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.

Sponsors & Collaborators

• Hospital Universiti Sains Malaysia: lead
• Ethos Healthcare Sdn Bhd company: collaborator

Study Sites (1)

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nani Draman, Masters

  Professor

  PRINCIPAL INVESTIGATOR

• Siti suhaila, Masters

  DR

  STUDY CHAIR

• NG Ying ying, Masters

  DR

  STUDY CHAIR

• Najib Majdi, PHD

  Prof

  STUDY CHAIR

• Khairun Nisah Ibrahim, Masters

  Miss

  STUDY CHAIR

• Kanmani Kumaran, MD

  DR

  STUDY CHAIR

Central Study Contacts

kanmani kumaran, MD

CONTACT

+60135125136; kanmanikumaran@yahoo.com

Nani Draman, Masters

CONTACT

+601115184421; drnani@usm.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: The participants then will be randomized to either intervention or control group. Both groups will receive diet consultation and dietary assessment using a 24-hour diet recall form from Dietitian in study team at Dietetic Clinic, Hospital USM. Those in the intervention group will receive diet consultation and meal replacement therapy Contro Eazy Now (CEN). The control group will get diet consultation.

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: March 6, 2025
• Study Start: November 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: March 1, 2026
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)