Effects of Growth Hormone Therapy on Liver Metabolism After Pituitary Surgery

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.

This study is testing whether growth hormone therapy can help people who had pituitary surgery and now have low growth hormone levels by improving their liver health and metabolism.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06448195 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of recombinant human growth hormone therapy on metabolic function in patients who have undergone surgery for pituitary adenomas and are experiencing adult growth hormone deficiency. The research focuses on how growth hormone treatment can improve lipid metabolism and reduce liver fat content, which is crucial for preventing further metabolic disorders such as diabetes and atherosclerosis. Participants will receive polyethylene glycol somatropin injections, and their liver fat content will be monitored using advanced imaging techniques. The study aims to provide insights into the effectiveness of growth hormone therapy in reversing metabolic dysfunction in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-60 diagnosed with adult growth hormone deficiency following pituitary adenoma surgery, with liver fat content exceeding 11%.

Not a fit: Patients with significant liver disease history or those currently on lipid-regulating medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve metabolic health and reduce the risk of serious complications for patients with growth hormone deficiency post-surgery.

How similar studies have performed: While there is limited research specifically on this approach, existing studies suggest that growth hormone therapy can positively influence lipid metabolism in similar patient populations.

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.

Where this trial is running

Shanghai

• Shanghai Zhongshan Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Tao Xie, doctorate

Conditions Growth Hormone Treatment