Growth Hormone-secreting Pituitary Adenoma (GH-PA)
Conditions
Interventions
Bromocentine Group:bromocentine mesylate tablet, starting dose is 0.625-1.25mg/d and the weekly increase of 1.25mg/d until 10-15mg/d.
Bromocentine and Metformin Group:metformin hydrochloride enteric solution 0.5g three times a day added on the basis of bromocentine mesylate tablet
Gamma Knife Radiosurgery Group:Gamma Knife Radiosurgery
Gamma Knife Radiosurgery and Metformin Group:metformin hydrochloride enteric solution 0.5g three times a day added on the basis of gamma knife radiosurgery
Sponsors
Department of Endocrinology, Second Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. GH-PA included were diagnosed according to criteria recommended by the Chinese guidelines for the diagnosis and treatment of acromegaly (2013) and the 2011 AACE guidelines for the diagnosis and treatment of acromegaly (updated): (1) had facial appearance change, headache, visual visual impairment and other related acromegaly clinical manifestations; (2) random serum GH >2.5 ng/ml and GH nadir levels >1ng/ml at all test time points within the 2 h post oral glucose load for an oral glucose tolerance test (OGTT), had serum IGF-I level over the upper limit of the age- and sex-matched normal range (ULN); (3) pituitary adenoma (microadenoma or macroadenoma) identified by MRI. 2. Aged 18–70 years; 3. provided written informed consent in accordance with local regulations.
Exclusion criteria
Exclusion criteria: 1. had obvious symptoms and signs of liver and kidney diseases, or the following parameters >2×ULN: aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum creatinine > 135 mmol/L (1.5 mg/dL) for male and>110 mmol/L (1.3 mg/dL) for female; 2. had used metformin or other insulin sensitizer within 1 month before inclusion; 3. receiving corticosteroid therapy or receiving malignant tumor therapy; 4. a history of substance or alcohol abuse in the past 2 years; 5. had spontaneous or familial tremor, Huntington's disease, and various types of endogenous psychosis; 6. had severe infection, trauma, surgery, heart failure, acute myocardial infarction, hypotension and hypoxia; 7. had serious cardiovascular disease, untreated hypertension, pulmonary insufficiency; 8. had malignant tumor within 2 years; 9.pregnant or planning to pregnant; 10.participated in clinical trials of other drugs within 30 days; 11.had other situations in which the intervention cannot be completed; 12.The researchers consider that the subjects had diseases effecting the results or were not fit for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| glucose;blood lipid;hand wide;hand length;finger wide;the first phalanges of the fingers;the second phalanges of the fingers;the third phalanges of the fingers;foot length;foot wide;feet rounding;glycohemoglobin;Insulin release test;C peptide release test;hepatic steatosis;myocardial enzyme;doppler echocardiography;pituitary MRI scan; | — |
Countries
China
Contacts
Public ContactRufei Shen
Department of Endocrinology, Second Affiliated Hospital of Army Medical University
Outcome results
None listed