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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT07285135
Eligibility Criteria:
Inclusion Criteria:
All subjects:
1. Age 21-70 years
2. Ability to provide informed consent.
MASLD group:
1. Hepatic steatosis on MRI
2. BMI of 25-50 kg/m2
Controls:
1. Absence of hepatic steatosis on MRI
2. BMI of 18.5-24.9 kg/m2
3. No chronic disease
4. No long-term medications
Exclusion Criteria:
1. Uncontrolled diabetes (HbA1c \> 8%)
2. Type 1 Diabetes Mellitus
3. Clinically significant anemia (Haemoglobin \< 10 g/dL)
4. Chronic liver disorders (except MASLD) such as Hepatitis B, Hepatitis C, Wilson's disease, hemochromatosis, autoimmune hepatitis, chronic cholestatic disorders, and liver cirrhosis
5. Drugs that may induce hepatic steatosis, such as methotrexate, amiodarone, tamoxifen, or Systemic steroid usage (eg. prednisolone, hydrocortisone, cortisone, dexamethasone)
6. Glomerular filtration rate (GFR \< 30 ml/min)
7. Serum alanine transaminase (ALT) \> 3x upper limit of normal (ULN)
8. Serum aspartate transaminase (AST) \> 3x ULN
9. Liver cirrhosis
10. Significant alcohol consumption (\> 20g/day for women and \>30g/day for men)
11. Receiving weight loss medications or GLP-1 receptor agonists
12. Pregnancy
13. Uncontrolled thyroid disease
14. Previous bariatric surgery
15. Weight loss \> 5% in the past 1 month
16. Metallic implants (including incompatible pacemakers, AICD, metallic heart valves) or other contraindications to MRI
17. Claustrophobia
18. Any factors likely to limit adherence to study protocol (e.g., dementia; alcohol or substance abuse; history of unreliability in medication taking or appointment keeping; significant concerns about participation in the study from spouse, significant other, or family members)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT07285135
Study Brief:
Protocol Section:
NCT07285135