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:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT01277094
Eligibility Criteria:
Inclusion Criteria:
* Adult patients, 35-65 years of age
* Hepatic steatosis assessed by magnetic resonance spectroscopy (MRS) with liver fat \>5.56% at screening
* Body mass index (BMI) \>27 kg/m2 at screening
* Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR) \> 2.5 at screening
* Agreement to maintain prior diet and exercise habits during the full course of study
Exclusion Criteria:
* History of diabetes mellitus based on World Health Organization (WHO) criteria
* Known polycystic ovary syndrome
* Other liver disease e.g. chronic viral hepatitis, alcoholic liver disease, hemachromatosis, cirrhosis
* Known autoimmune disease or chronic inflammatory disease
* Myocardial infarction or stroke within 6 months prior to screening
* Patients taking any anti-diabetic and/or weight-lowering medication currently or within the previous 3 months before screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
65 Years
Study:
NCT01277094
Study Brief:
Protocol Section:
NCT01277094