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 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT05751720
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18; either male or female
* Diagnosed to have Type 2 Diabetes Mellitus for \> 1 year.
* Presence of NAFLD advanced fibrosis (F3 and F4; defined by NFS of \> 0.676)
* Able to consent independently
* Not already on GLP-1 analogues or SGLT2 inhibitors or pioglitazone
* Good general health
* BMI\> 19 but less than 40
Exclusion Criteria:
* Known history of alcohol excess or current alcohol use of \> 20 g/week
* Evidence of pre-existing liver or biliary disease (hepatoma, biliary tract obstruction; liver cirrhosis secondary to viral infection or immune/ congenital).
* Known or suspected hypersensitivity to GLP-1 analogues or pioglitazone.
* Receipt of any investigational medicinal product within 30 days before screening.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods.
* Endocrinopathies (e.g., Cushing syndrome)
* Personal history of heart disease especially heart failure
* History of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.
* eGFR \< 30
* history of heamturia or bladder cancer
* history of osteoporosis
* ALT ≥3.5 times the upper normal limit (UNL)
* Taking steroids, antipsychotics or progesterone preparations
* Uncontrolled hypertension
* Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.
* HbA1c \> 10%
* Claustrophobia or unable to get MRI due to contraindications (e.g metal in the body)
* Weight \> 150 kg (due to imaging trolley restrictions)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05751720
Study Brief:
Protocol Section:
NCT05751720