Growth Hormone TreatmentPhase 4NCT06448195
Effects of Growth Hormone Therapy on Metabolic Function in Fatty Liver Post-Pituitary Adenoma Surgery
A Phase 4 study testing Polyethylene Glycol Somatropin (rDNA origin) Injection in people with Growth Hormone Treatment, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Growth Hormone Treatment
- What is being tested?
- Polyethylene Glycol Somatropin (rDNA origin) Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Zhongshan Hospital
Shanghai, 200032
Tao Xie, doctorate, 13524281211, xie.tao@zs-hospital.sh.cn
About this study
Official title: 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.
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.
Read the detailed description
Growth Hormone (GH) is an important hormone secreted by the pituitary gland and is essential for maintaining normal fat, muscle, bone content, and energy balance in the body. The prevalence of adult Growth Hormone Deficiency (GHD) is approximately 0.3% in adults. When human growth hormone is deficient, lipid metabolism is most prone to disorder. The study found that blood triglyceride and low-density lipoprotein cholesterol levels increased in GHD patients, and blood high-density lipoprotein cholesterol levels decreased. GHD is most common in patients with pituitary tumor after surgery or radiotherapy, especially in patients with GH adenoma after surgery. The lipid metabolism disorder is the most serious among all GHD patients because the excessive growth hormone before surgery has caused a state of severe lipid metabolism disorder, and after surgery, patients are directly converted to a state of growth hormone deficiency, exacerbating the lipid metabolism disorder. This disorder will progress from poor to worse, and long-term follow-up shows a higher likelihood of developing secondary atherosclerotic diseases post-surgery.
Current studies have shown that when abnormal lipid metabolism occurs in GHD patients, fat will first accumulate in the liver. Therefore, compared with changes in blood lipid metabolism indexes and body components, changes in liver fat content can detect abnormal lipid metabolism earlier. Liver fat deposition, as the initiating factor of systemic metabolic disorders, is involved in the occurrence and development of diabetes and atherosclerotic diseases. Currently, it is considered that the fat deposition in Nonalcoholic Fatty Liver Disease (NAFLD) is reversible. Therefore, it is particularly urgent to conduct very early intervention for GHD patients with pituitary GH adenoma after operation to block the occurrence of subsequent metabolic adverse events.
It has been reported that recombinant human growth hormone can be used in the treatment of abnormal lipid metabolism due to GHD, but at present, there is a lack of relevant studies on recombinant human growth hormone in the treatment of abnormal lipid metabolism in patients with pituitary GH adenoma after surgery, especially the study on the change of liver fat content. The investigators intend to apply a recombinant human growth hormone dose of 1 mg/week (6 IU is 1 mg) to GH adenoma patients with GHD and NAFLD after GH adenoma surgery, aiming to increase the insulin-like growth factor-1 of patients to the median of the normal level of peers, with a treatment duration of 24 weeks. After treatment, changes in liver fat content at baseline and 24 weeks after intervention will be measured by proton magnetic resonance spectroscopy (1H MRS) and Fibroscan liver stiffness. The changes in metabolic parameters (body weight, body mass index (BMI), waist circumference, fasting blood glucose, blood lipids, high iron content, and other metabolic-related inflammatory factors) before and after recombinant human growth hormone treatment will be evaluated.
This study aims to evaluate the efficacy and safety of recombinant human growth hormone in the treatment of GHD-induced NAFLD patients with abnormal lipid metabolism after GH adenoma surgery and propose a suitable treatment method for people with abnormal lipid metabolism due to GHD after GH adenoma surgery, providing a direct basis for establishing a standardized clinical treatment path in the next step.
The Department of Neurosurgery of Zhongshan Hospital Affiliated to Fudan University carries out more than 300 cases of various types of pituitary tumors every year, including more than 100 cases of pituitary GH adenoma. It has developed a multidisciplinary joint clinic for pituitary tumors earlier in China and has rich experience in the diagnosis and treatment of pituitary tumors, meeting the needs of 40 enrolled cases. The Department of Endocrinology has been committed to the evaluation of lipid metabolism disorders in nonalcoholic fatty liver for a long time. Currently, ultrasound and imaging are proficient in non-invasive methods of determining liver fat, such as MRS liver stiffness test. As a large Class III hospital in Shanghai, with a wealth of pituitary tumor patients, it can meet the enrollment requirements of subjects, and the endocrinology department can complete the assessment of lipid metabolism disorder. Detailed exit criteria and rescue plans have been jointly developed. Adverse events that may occur during the study were defined and addressed in detail.
- Conditions
- Growth Hormone Treatment
- Being tested
- Polyethylene Glycol Somatropin (rDNA origin) Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene Glycol Somatropin (rDNA origin) InjectionDrug
Also called Growth hormone replacement therapy
Specification: 54IU/9.0mg/1.0ml/ bottle Dosage form: injection; Dose: 1mg/ week. Subcutaneous injection (upper arm, thigh or abdomen periumbilical) for a total course of 6 months, a total of 3 bottles per patient
| Study group | Role | What they receive |
|---|---|---|
| Growth hormone treatment group | Experimental | 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 Receives: Drug: Polyethylene Glycol Somatropin (rDNA origin) Injection |
| Lifestyle intervention control group | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of liver fat
To evaluate the effect of recombinant growth hormone replacement therapy on hepatic fat content in NAFLD patients with GHD after pituitary GH adenoma surgery
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone TreatmentStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Xie, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448195
- Sponsor's protocol ID
- B2024-071R2
- Status last verified
- Jun 2024
- First submitted
- 28 May 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06448195
- Acronym / sponsor ID
- B2024-071R2
- Conditions
- Growth Hormone Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Growth Hormone (GH) is an important hormone secreted by the pituitary gland and is essential for maintaining normal fat, muscle, bone content, and energy balance in the body. The prevalence of adult Growth Hormone Deficiency (GHD) is approximately 0.3% in adults. When human growth hormone is deficient, lipid metabolism is most prone to disorder. The study found that blood triglyceride and low-density lipoprotein cholesterol levels increased in GHD patients, and blood high-density lipoprotein cholesterol levels decreased. GHD is most common in patients with pituitary tumor after surgery or radiotherapy, especially in patients with GH adenoma after surgery. The lipid metabolism disorder is the most serious among all GHD patients because the excessive growth hormone before surgery has caused a state of severe lipid metabolism disorder, and after surgery, patients are directly converted to a state of growth hormone deficiency, exacerbating the lipid metabolism disorder. This disorder will progress from poor to worse, and long-term follow-up shows a higher likelihood of developing secondary atherosclerotic diseases post-surgery.
Current studies have shown that when abnormal lipid metabolism occurs in GHD patients, fat will first accumulate in the liver. Therefore, compared with changes in blood lipid metabolism indexes and body components, changes in liver fat content can detect abnormal lipid metabolism earlier. Liver fat deposition, as the initiating factor of systemic metabolic disorders, is involved in the occurrence and development of diabetes and atherosclerotic diseases. Currently, it is considered that the fat deposition in Nonalcoholic Fatty Liver Disease (NAFLD) is reversible. Therefore, it is particularly urgent to conduct very early intervention for GHD patients with pituitary GH adenoma after operation to block the occurrence of subsequent metabolic adverse events.
It has been reported that recombinant human growth hormone can be used in the treatment of abnormal lipid metabolism due to GHD, but at present, there is a lack of relevant studies on recombinant human growth hormone in the treatment of abnormal lipid metabolism in patients with pituitary GH adenoma after surgery, especially the study on the change of liver fat content. The investigators intend to apply a recombinant human growth hormone dose of 1 mg/week (6 IU is 1 mg) to GH adenoma patients with GHD and NAFLD after GH adenoma surgery, aiming to increase the insulin-like growth factor-1 of patients to the median of the normal level of peers, with a treatment duration of 24 weeks. After treatment, changes in liver fat content at baseline and 24 weeks after intervention will be measured by proton magnetic resonance spectroscopy (1H MRS) and Fibroscan liver stiffness. The changes in metabolic parameters (body weight, body mass index (BMI), waist circumference, fasting blood glucose, blood lipids, high iron content, and other metabolic-related inflammatory factors) before and after recombinant human growth hormone treatment will be evaluated.
This study aims to evaluate the efficacy and safety of recombinant human growth hormone in the treatment of GHD-induced NAFLD patients with abnormal lipid metabolism after GH adenoma surgery and propose a suitable treatment method for people with abnormal lipid metabolism due to GHD after GH adenoma surgery, providing a direct basis for establishing a standardized clinical treatment path in the next step.
The Department of Neurosurgery of Zhongshan Hospital Affiliated to Fudan University carries out more than 300 cases of various types of pituitary tumors every year, including more than 100 cases of pituitary GH adenoma. It has developed a multidisciplinary joint clinic for pituitary tumors earlier in China and has rich experience in the diagnosis and treatment of pituitary tumors, meeting the needs of 40 enrolled cases. The Department of Endocrinology has been committed to the evaluation of lipid metabolism disorders in nonalcoholic fatty liver for a long time. Currently, ultrasound and imaging are proficient in non-invasive methods of determining liver fat, such as MRS liver stiffness test. As a large Class III hospital in Shanghai, with a wealth of pituitary tumor patients, it can meet the enrollment requirements of subjects, and the endocrinology department can complete the assessment of lipid metabolism disorder. Detailed exit criteria and rescue plans have been jointly developed. Adverse events that may occur during the study were defined and addressed in detail.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Growth hormone treatment group | Experimental | Drug: Polyethylene Glycol Somatropin (rDNA origin) InjectionA 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 |
| Lifestyle intervention control group | No intervention | –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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyethylene Glycol Somatropin (rDNA origin) InjectionAlso: Growth hormone replacement therapySpecification: 54IU/9.0mg/1.0ml/ bottle Dosage form: injection; Dose: 1mg/ week. Subcutaneous injection (upper arm, thigh or abdomen periumbilical) for a total course of 6 months, a total of 3 bottles per patient | Drug | Growth hormone treatment group |
Primary outcome
the percentage of liver fat
Time frame: up to 6 months
To evaluate the effect of recombinant growth hormone replacement therapy on hepatic fat content in NAFLD patients with GHD after pituitary GH adenoma surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tao Xie study director
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polyethylene Glycol Somatropin (rDNA origin) Injection in people with Growth Hormone Treatment, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Xie, doctorate (13524281211, xie.tao@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of liver fat (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.