Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT01906359
Eligibility Criteria:
Inclusion Criteria:
1. Mild T2DM individuals not planned for medical intervention
* 7.0 mmol/L ≤ fasting glucose ≤ 11.1 mmol/L
* 6.5% ≤ HbA1c ≤ 9.0%
* Not using antihypertensive, lipid lowering, insulin/glucose modulating medication
2. Mild T2DM individuals currently on medical intervention
* Fasting glucose ≤ 11.1 mmol/L
* HbA1c ≤ 9.0%
* Using antihypertensive, lipid lowering or glucose modulating medication
3. Malaysian male or female with T2DM aged between 30 to 60 years old
4. Not using insulin
5. Not having any complications of diabetes
6. No medical history of myocardial infarction, angina, thrombosis, stroke or cancer
7. Haemoglobin levels for females ≥ 11.5 gm/dl and males ≥ 12.5 gm/dl
8. Serum ferritin \> 15 µg/l at commencement of study
Exclusion Criteria:
1. Medical history of myocardial infarction, angina, thrombosis, stroke or cancer
2. Underweight (BMI \< 18.5 kg/m²)
3. Using insulin
4. Total cholesterol \> 7.0 mmol/L
5. Abnormal liver function, renal function and haematology
6. Hypersensitive towards heparin
7. Gastric or lactose intolerance
8. Smoker
9. Pregnancy and lactating
10. Taking alcohol
11. Taking alcohol
12. Haemoglobin levels for females ≤ 11.5 gm/dl and males ≤ 12.5 gm/dl
13. Serum ferritin \< 15 µg/l at commencement of study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
60 Years
Study:
NCT01906359
Study Brief:
Protocol Section:
NCT01906359