Weight loss and glycaemic control in overweight and obese type 2 diabetes mellitus patients Nutritional, Metabolic, Endocrine
Conditions
Interventions
This is a two-armed randomised controlled clinical trial (RCT). Participants will be selected using purposive sampling based on the inclusion and exclusion criteria. Data collection will be conducted
Sponsors
Quantum Upstream Sdn Bhd
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 16/06/2026: 1. Malaysian 2. Aged 20-65 years old 3. Diagnosed with T2DM for at least 6 months with baseline HbA1c levels above 6.5–12 % for the past 6 months 4. Overweight or obese with BMI =23 kg/m² 5. Able to communicate and understand in English or Malay language _____ Previous key inclusion criteria as of 18/12/2025: 1. Malaysian 2. Aged 20-65 years old 3. Diagnosed with T2DM for at least 6 months with baseline HbA1c levels above 6.5–12 % for the past 6 months 4. Overweight or obese with BMI =25 kg/m² 5. Able to communicate and understand in English or Malay language _____ Previous inclusion criteria as of 09/04/2025: 1. Malaysian 2. Aged 30-65 years old 3. Diagnosed with T2DM for at least 6 months with baseline HbA1c levels above 7.5–12 % for the past 6 months 4. Overweight or obese with BMI =25 kg/m² 5. Able to communicate and understand in English or Malay language _____ Previous inclusion criteria: 1. Malaysian 2. Aged 30-59 years old 3. Diagnosed with T2DM for at least 6 months with baseline HbA1c levels above 7.5–12 % for the past 6 months 4. Overweight or obese with BMI =25 kg/m² 5. Able to communicate and understand in English or Malay language
Exclusion criteria
Exclusion criteria: 1. On insulin treatment 2. With hepatic disease (ALT >120 IU/L) 3. With chronic kidney disease (GFR <30 M1/min/1.73 m2) 4. Pregnant and lactating women 5. Currently consuming any weight reduction products or any slimming prescriptions or any meal replacement 6. Currently on hormone replacement therapy (HRT) 7. Cancer on treatment 8. Currently involved in weight loss programs or any clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Bodyweight and body composition will be measured by using the InBody 270 machine at baseline, weeks 6 and 12 2. Height will be measured using a SECA 217 stadiometer at baseline, weeks 6 and 12 3. Waist and hip circumference will be measured using SECA measuring tape at baseline, weeks 6 and 12 4. BMI will be calculated using a formula (weight in kilograms divided by height in meters squared) and the WHO cut-off point at baseline, weeks 6 and 12 5. Glycaemic control will be measured by HbA1c and fasting blood sugar at baseline and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Lipid profile will be measured by taking blood samples at baseline and week 12 2. Renal profile will be measured by taking blood samples at baseline and week 12 3. Liver profile will be measured by taking blood samples at baseline and week 12 4. Dietary intake will be measured using a 3-day diet history questionnaire at baseline, weeks 6 and 12 5. Physical activity will be measured by using a global physical activity questionnaire (GPAQ) Malay at baseline, weeks 6 and 12 6. Satiety level will be assessed by using a visual analogue scale (VAS) at specified intervals of 30, 60, 120, 180 and 240 minutes after consumption at baseline, weeks 6 and 12 7. Quality of life will be assessed using a diabetes-dependent quality of life questionnaire at baseline and week 12 8. Cost analysis will be calculated based on the Net Present Value formula at week 12 9. Metabolic gene expression profile will be measured using nCounter from NanoString at baseline and week 12 | — |
Countries
Malaysia
Contacts
Public ContactMunirah;Wan Ain Nadirah Ismail;Che Wan Mansor
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Outcome results
None listed