Growth Hormone Replacement Therapy on Metabolic Effects in Patients With Fatty Liver Caused by Growth Hormone Deficiency After Pituitary GH Adenoma Surgery: A Monocentric, Prospective, Randomized, Parallel-controlled Clinical Study.

B2024-071R2

Growth Hormone (GH) is essential for maintaining fat, muscle, bone, and energy balance. Adult Growth Hormone Deficiency (GHD) affects about 0.3% of adults. GHD, common post-pituitary tumor surgery or radiotherapy, disrupts lipid metabolism, increasing triglycerides and low-density lipoprotein cholesterol while decreasing high-density lipoprotein cholesterol. This is especially severe in GH adenoma patients, whose lipid metabolism issues worsen post-surgery, increasing the risk of atherosclerosis. Fat accumulates in the liver first, making liver fat content a key early indicator of metabolic disorders, which can lead to diabetes and atherosclerosis. Early intervention is crucial as liver fat deposition in Nonalcoholic Fatty Liver Disease (NAFLD) is reversible. Recombinant human growth hormone can treat GHD-related lipid metabolism disorders, but research on its effects on liver fat in post-surgery GH adenoma patients is limited. The investigators plan to treat these patients with 1 mg/week of recombinant human growth hormone for 24 weeks, aiming to normalize insulin-like growth factor-1 levels. Liver fat content changes will be measured using proton magnetic resonance spectroscopy (1H MRS) and Fibroscan. Changes in weight, BMI, waist circumference, fasting blood glucose, blood lipids, and other metabolic factors will also be evaluated to assess treatment efficacy and safety. Zhongshan Hospital, affiliated with Fudan University, performs over 300 pituitary tumor surgeries annually, including 100 GH adenoma cases. The hospital has extensive experience and can enroll 40 patients. The Endocrinology Department excels in evaluating lipid metabolism disorders in NAFLD using non-invasive methods. As a major hospital in Shanghai, it has ample patients to meet study requirements. Detailed exit criteria and rescue plans have been established to address potential adverse events during the study.

2023-01-01

2024-12-31

2025-12-31

Recruiting

Early phase I

40

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2024-06-10