Actively Recruiting

Phase 4
Age: 18Years - 60Years
All Genders
NCT06448195

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

Led by Shanghai Zhongshan Hospital · Updated on 2024-06-10

40

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 60 years
  • Diagnosed with adult growth hormone deficiency (GH peak 645 ug/l or organic hypothalamic-pituitary disease with 3 or more pituitary hormone deficiencies and IGF-1 less than -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
  • No use of lipid-regulating drugs such as statins or Bates
  • Blood pressure below 150/95 mmHg without antihypertensive drugs
Not Eligible

You will not qualify if you...

  • History of liver diseases such as chronic hepatitis, cirrhosis, liver cancer, autoimmune liver disease, alcoholic liver disease, or hereditary liver disease
  • Significant abnormal liver function (ALT or AST at least twice the upper normal limit; HBsAg positive and/or HCV antibody positive)
  • Serum creatinine value 1.5 mg/dL (133 umol/L) or higher
  • Severe heart disease including history of myocardial infarction, heart failure, or severe arrhythmia
  • Severe infection, surgery within 6 months, or severe trauma
  • Alcohol consumption above 140g/week for males or 70g/week for females
  • Poorly controlled diabetes with HbA1c over 9.5% in the last 3 months or use of certain hypoglycemic drugs affecting liver histology
  • Allergy or intolerance to the study drug
  • Planned pregnancy, breastfeeding, or mental disorders within the next year
  • Participation in other clinical trials within 24 weeks

AI-Screening

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Trial Site Locations

Total: 1 location

1

Shanghai Zhongshan Hospital

Shanghai, China, 200032

Actively Recruiting

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Research Team

T

Tao Xie, doctorate

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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