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 @ 1:20 PM
Ignite Modification Date:
2025-12-24 @ 1:20 PM
NCT ID:
NCT06448195
Eligibility Criteria:
Inclusion Criteria:
* Have fully understood the informed consent and signed the informed consent;
* Age: 18-60 years old;
* Patients diagnosed with adult growth hormone deficiency (AGHD) (GH stimulation test: GH peak ≤5ug/l or organic hypothalamic-pituitary disease ≥3 pituitary hormone deficiency with IGF-1 \< -2SD)
* Patients with pituitary growth hormone adenoma proved pathologically after surgery
* Anterior pituitary hormone supplementation (except growth hormone)
* The liver fat content was more than 11% after six months to two years of operation by proton magnetic resonance spectroscopy (1H MRS).
* Those who have not taken lipid-regulating drugs (statins, Bates);
* Blood pressure \<150/95mmHg, did not take any antihypertensive drugs;
Exclusion Criteria:
* Have any of the following liver disease history: chronic hepatitis, cirrhosis, liver cancer, autoimmune liver disease, alcoholic liver disease, hereditary liver disease
* Significant abnormal liver function: ALT or AST≥ 2 times the upper limit of normal; HBsAg (+), and/or HCV-Ab (+);
* Patients with serum creatinine value ≥1.5mg/dL (133umol/L);
* Patients with severe heart disease (patients with a history of myocardial infarction and heart failure and/or severe arrhythmia);
* Patients with severe infection, other operations within 6 months, or severe trauma;
* Alcohol consumption (alcohol): male ≥140g/week; Female ≥70g/week;
* Poorly controlled diabetic patients: HbA1c \>9.5% within three months; Or use hypoglycemic drugs that may affect liver histopathology, including pioglitazone, GLP-1, and DP-4 inhibitors;
* Patients with allergy or intolerance to the same drug used in the trial;
* In the next 1 year, there are pregnancy plans or breastfeeding patients or patients with mental disorders;
* Patients who have participated in other clinical trials within 24 weeks.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06448195
Study Brief:
Protocol Section:
NCT06448195