Pituitary Stalk Interruption Syndrome
Conditions
Interventions
Treatment group:Jintrolong
Control group:Placebo
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: Subjects: Patients with pituitary stalk interruption syndrome (PSIS) complicated with non-alcoholic fatty liver disease (NAFLD) diagnosed in our hospital. PSIS will be diagnosed if the patient has multiple (>=2) pituitary hormone deficiency, and MRI in the saddle region shows slender, interrupted or absent pituitary stalk, hypoplasia of anterior pituitary lobe, ectopic or absent posterior pituitary lobe, and hypopituitarism caused by other causes is excluded. Patients must meet all of the following inclusion criteria to be enrolled in this study: 1.20-40 years, epiphyseal is basically closed, linear growth has been completed and year end height has been achieved; 2.In the presence of 1-2 pituitary hormone deficiency and IGF-1=6%. If imaging suggested cirrhosis, the Child Pugh grade was GRADE A; 5.They are willing to sign informed consent before the activities related to the study, understand the procedures and methods of the study, and are willing to strictly abide by the clinical trial protocol to complete all the treatment and visit plans of the study, and cooperate with relevant examinations.
Exclusion criteria
Exclusion criteria: Subjects with any of the following criteria will not be enrolled in this study: 1.Heavy alcohol consumption: >21 units of alcohol per week for men and >14 units of alcohol per week for women (1 unit = 375mL 3.5% alcohol beer or 30mL 40% alcohol spirits or 100ml 13.5% alcohol red wine; 2.Other diseases that can lead to fatty liver, such as history of drug intake that can cause fatty liver (such as tamoxifen, amiodarone, sodium valproate, methotrexate, supersphysiological dose of glucocorticoid, etc.), hepatitis virus infection, autoimmune hepatitis, Wilson's disease, etc.; 3.The patient is using other concomitant drugs that can improve fatty liver, including but not limited to metformin, GLP-1 receptor agonist, SGLT-2 inhibitor, TZDs, vitamin E and other drugs; 4.Severe abnormal liver function, i.e. ALT or AST exceeding the upper limit of 5 times normal; The Child Pugh grade of cirrhosis patients was GRADE B or C, or the late complications of cirrhosis (portal hypertension, hepatic encephalopathy, hepatopulmonary syndrome, etc.) or hepatocellular carcinoma; 5.Severe renal dysfunction, i.e. eGFR 140mmHg or diastolic blood pressure >90mmHg under treatment), and patients with recent severe stroke; 7.Diabetic patients; 8.Patients considered at risk for gh therapy if head MRI at screening/baseline showed concomitant abnormalities such as intracranial space occupation in addition to PSIS; 9.Patients with other serious diseases that affect the completion of the trial protocol; 10.With somatropin therapy contraindications: acute proliferative or serious non proliferative diabetic retinopathy, has a history of malignant tumor before or now history, family history of cancer (immediate relatives within three generations in the two people have two or more people past history of tumor or hpi), 2 consecutive tumor markers over upper limit of normal range, and so on and so forth; 11.Highly allergic or suspected by the investigator that the subject may be allergic to the study drugs and excipients; 12.Subjects with metal substances or other contraindications for MRI examination; 13.Pregnant or lactating women; Women who plan to become pregnant within a year; Women of reproductive age, male subjects and their spouses are unwilling to use medically approved contraceptive methods; 14.Participated in clinical trials of any drug or medical device within 3 months prior to screening (except those who signed ICF only and did not receive any drug or device intervention); 15.Other conditions that the investigator considers inappropriate for inclusion in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver fat content; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver stiffness;Visceral adipose tissue and subcutaneous adipose tissue;Glucolipid metabolism index; | — |
Countries
China
Contacts
Public ContactWu Xueyan
Peking Union Medical College Hospital
Outcome results
None listed