The Effect and safety Assessment of Metformin Therapy in Growth Hormone-secreting Pituitary Adenoma (GH-PA) Patients who inoperable or incomplete control after surgery

• Register: ChiCTR
• Last refreshed on: 20 August 2018
• Main ID: ChiCTR1800017714
• Date of registration: 2018-08-10
• Prospective Registration: Yes
• Primary sponsor: Department of Endocrinology, Second Affiliated Hospital of Army Medical University
• Public title: The Effect and safety Assessment of Metformin Therapy in Growth Hormone-secreting Pituitary Adenoma (GH-PA) Patients who inoperable or incomplete control after surgery
• Scientific title: The Effect and safety Assessment of Metformin Therapy in Growth Hormone-secreting Pituitary Adenoma (GH-PA) Patients who inoperable or incomplete control after surgery
• Date of first enrolment: 2019-01-01
• Target sample size: Bromocentine Group:10;Bromocentine and Metformin Group:10;Gamma Knife Radiosurgery Group:10;Gamma Knife Radiosurgery and Metformin Group:10;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=29947
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: New Treatment Measure Clinical Study

Countries of recruitment

China

Contacts

• Name: Rufei Shen
• Affiliation: Department of Endocrinology, Second Affiliated Hospital of Army Medical University

• Name: Rufei Shen
• Affiliation: Department of Endocrinology, Second Affiliated Hospital of Army Medical University

Key inclusion & exclusion 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: 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.

Age minimum: 18
Age maximum: 70
Gender: Both

Health Condition(s) or Problem(s) studied

Growth Hormone-secreting Pituitary Adenoma (GH-PA)

Intervention(s)

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;

Primary Outcome(s)

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;

Source(s) of Monetary Support

None

Ethics review

Status: Not approved
Approval date: 26/08/2013
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