Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448195
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-28
Brief Title:
Effects of Growth Hormone Therapy on Metabolic Function in Fatty Liver Post-Pituitary Adenoma Surgery
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Growth Hormone GH is essential for maintaining fat muscle bone and energy balance Adult Growth Hormone Deficiency GHD affects about 03 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 mgweek 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
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 mgweek 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 03 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 mgweek 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
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 mgweek 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None