Effects of Growth Hormone Therapy on Metabolic Function in Fatty Liver Post-Pituitary Adenoma Surgery

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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);

Trial design

Treatments tested in this trial

  • Polyethylene Glycol Somatropin (rDNA origin) Injection

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators