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

NCTNCT06448195Other idB2024-071R2

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Overview

Status: Status unknown
Phase: Phase 4
Enrollment: 40 participants (estimated)
Sponsor: Shanghai Zhongshan Hospital · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
China
Start: 1 Jan 2023
Primary completion: 31 Dec 2024 (estimated)
Completion: 31 Dec 2025 (estimated)
First posted: 7 Jun 2024
Last update posted: 10 Jun 2024
Conditions: Growth Hormone Treatment

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2023202420252026

Ph 4
Effects of Growth Hormone Therapy on Metabolic Function in Fatty Liver Post-Pituitary Adenoma Surgery
NCT06448195
1 Jan 2023 to est. 31 Dec 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Polyethylene Glycol Somatropin (rDNA origin) InjectionDrug

Arms2

Experimental
Growth hormone treatment group
A total of 20 patients with liver fat content greater than 11% determined by proton magnetic resonance spectroscopy (1H MRS) method were recruited six months to two years after operation of pituitary adenoma, and underwent growth hormone replacement therapy, the total course of treatment was 6 months, and finally the liver fat content was determined
No intervention
Lifestyle intervention control group
A total of 20 patients with liver fat content greater than 11% determined by proton magnetic resonance spectroscopy (1H MRS) method were recruited six months to two years after operation of pituitary adenoma. The patients were treated as the control group and underwent lifestyle intervention. Finally, the liver fat content was determined

Primary outcomes1

Outcomes the sponsor listed as primary.

the percentage of liver fat
Time frame · up to 6 months
Registry description
To evaluate the effect of recombinant growth hormone replacement therapy on hepatic fat content in NAFLD patients with GHD after pituitary GH adenoma surgery

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

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Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 60 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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