Actively Recruiting
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
Led by Shanghai Zhongshan Hospital · Updated on 2024-06-10
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Growth Hormone (GH) plays a crucial role in maintaining healthy fat, muscle, bone, and energy balance. Adult Growth Hormone Deficiency (GHD), affecting about 0.3% of adults, is common after pituitary tumor surgery or radiotherapy, especially in patients with GH adenoma. These patients often experience severe lipid metabolism problems that worsen after surgery, increasing risks for atherosclerosis. Fat accumulation in the liver is an early sign of metabolic issues leading to diabetes and heart disease, and early intervention is important because this liver fat buildup in Nonalcoholic Fatty Liver Disease (NAFLD) can be reversed. The study evaluates the effects of recombinant human growth hormone treatment given as a 1 mg weekly subcutaneous injection over 24 weeks to patients with GHD and NAFLD after GH adenoma surgery. Participants are divided into two groups: one receiving growth hormone replacement therapy and the other receiving lifestyle intervention as a control. Changes in liver fat content will be measured using proton magnetic resonance spectroscopy (1H MRS) and Fibroscan, alongside assessments of weight, BMI, waist size, blood glucose, blood lipids, and other metabolic markers. Participants will be monitored at baseline and after 24 weeks of treatment. Researchers will evaluate the percentage of liver fat as the primary outcome, as well as safety and changes in metabolic factors. The study is conducted at Zhongshan Hospital with a plan to enroll 40 patients meeting specific criteria. Detailed safety and exit plans are in place, and the hospital has extensive experience in pituitary tumor surgery and managing metabolic disorders related to fatty liver disease.
CONDITIONS
Brief Title
Effects of Growth Hormone Therapy on Metabolic Function in Fatty Liver Post-Pituitary Adenoma Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have fully understood and signed the informed consent
- Age between 18 and 60 years
- Diagnosed with adult growth hormone deficiency (GH peak ≤5ug/l or organic hypothalamic-pituitary disease with ≥3 pituitary hormone deficiencies and IGF-1 < -2SD)
- Pathologically confirmed pituitary growth hormone adenoma after surgery
- Receiving anterior pituitary hormone supplementation except growth hormone
- Liver fat content greater than 11% measured 6 months to 2 years after surgery by proton magnetic resonance spectroscopy (1H MRS)
- Have not taken lipid-regulating drugs such as statins or Bates
- Blood pressure less than 150/95 mmHg without antihypertensive medication
You will not qualify if you...
- History of liver diseases including chronic hepatitis, cirrhosis, liver cancer, autoimmune liver disease, alcoholic liver disease, or hereditary liver disease
- Significant abnormal liver function (ALT or AST ≥ 2 times upper limit of normal) or positive for hepatitis B surface antigen or hepatitis C antibody
- Serum creatinine value ≥1.5 mg/dL (133 umol/L)
- Severe heart disease such as history of myocardial infarction, heart failure, or severe arrhythmia
- Severe infection, other surgeries within 6 months, or severe trauma
- Alcohol consumption above 140g/week for males or 70g/week for females
- Poorly controlled diabetes (HbA1c >9.5% within 3 months) or use of hypoglycemic drugs affecting liver histopathology (pioglitazone, GLP-1, DP-4 inhibitors)
- Allergy or intolerance to the study drug
- Pregnancy plans, breastfeeding, or mental disorders within the next year
- Participation in other clinical trials within the last 24 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive weekly subcutaneous injections of recombinant human growth hormone for 24 weeks to evaluate effects on liver fat content and metabolic function.
Weekly visits for up to 24 weeks
Duration - Up to 6 months
Participants are monitored after treatment completion to assess changes in liver fat and metabolic parameters.
1 visit at 24 weeks after treatment
Trial Site Locations
Total: 1 location
1
Shanghai Zhongshan Hospital
Shanghai, China, 200032
Actively Recruiting
Research Team
T
Tao Xie, doctorate
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here