Hormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues

Asan Medical Center1 enrolled

Overview

Long-term (up to 3 years) clinical and hormonal outcomes in acromegalic patients with treated surgery with or without long acting somatostatin analogues.

Patients who are diagnosed with acromegaly with a GH-secreting pituitary adenoma receiving TSA at the Asan Medical Center (Seoul, Korea) from Aug 2013 to Aug 2015 will be recruited. The eligible patient population will consist of 30 adult, male and female patient with Age 18 or older. * Number of patients by treatment group: Surgical treatment only = 15, Surgery with medical treatment = 15 * Number of Centers: 1 (single center)

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acromegaly

Interventions

Sandostatin (Octreotide Acetate)DRUG

For the patients outlined above (refer to 2), subjects who are not able to be treated by surgery alone: * Dose: Sandostatin LAR® 20mg per 4 weeks for 3 months -\> If serum IFG-1 levels fails to normalize, the dose of LAR will be increased to 30 mg. * Frequency: every 4 weeks. * Route of administration: IM injection.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18 or older. 2. Patients diagnosed with acromegaly with GH-secreting pituitary adenoma on sellar MRI, meeting the biochemical criteria outlined above (refer to 1. Diagnosis of acromegaly) and with typical acromegalic features. 3. No prior use of somatostatin analogues. 4. Adequate hepatic and renal function 5. Provision of a signed written informed consent Exclusion Criteria: 1. Severe co-morbid illness such as untreatable other malignancy and/or active infections. 2. Pregnant or lactating women 3. Hypersensitivity to Sandostatin or any component of the formulation.

Locations (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Number of patients who achieved normalization of fasting serum IGF-1 (age and sex matched)

Time frame: Change from within 3days post-operative in fasting serum IGF-1at 36 months post-operative

The time taken to IGF-1 normalization in each group.

Time frame: Change from within 3days post-operative in IGF-1 normalization at 36 months post-operative months post-operative

Secondary Outcomes

GH suppressive responses (a nadir GH < 0.4 ng/ml) to oral glucose

Time frame: Change from Pre-operative in GH suppressive responses (a nadir GH < 0.4 ng/ml) at 36 months post-operative

Clinical symptom and sign with AcroQoL questionnaire

Time frame: Change from Pre-operative in Clinical symptom and sign with AcroQoL questionnaire at 36 months post-operative

Sleep quality and disturbance with written questionnaire

Time frame: Change from Pre-operative in Sleep quality and disturbance with written questionnaire at 24 months post-operative

fasting glucose , postprandial glucose

Time frame: Change from pre-operative in fasting glucose , postprandial glucose at 36 months post-operative.

insulin

Time frame: Change from pre-operative in insulin at 36 months post-operative.

HbA1c

Time frame: change from pre-operative in HbA1c at 36 months post-operative.

Central Contacts

minseon Kim, PhD

CONTACT

82-2-3010-3245 mskim@amc.seoul.kr

heesun Park, college

CONTACT

82-2-3010-4135 guccienvy2@naver.com

Data from ClinicalTrials.gov

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