Acromegaly
Conditions
Brief summary
Long-term (up to 3 years) clinical and hormonal outcomes in acromegalic patients with treated surgery with or without long acting somatostatin analogues.
Detailed description
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)
Interventions
DRUGSandostatin (Octreotide Acetate)
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.
Sponsors
Novartis Korea Ltd.
Asan Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients who achieved normalization of fasting serum IGF-1 (age and sex matched) | 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. | Change from within 3days post-operative in IGF-1 normalization at 36 months post-operative months post-operative |
Secondary
| Measure | Time frame |
|---|---|
| Sleep quality and disturbance with written questionnaire | Change from Pre-operative in Sleep quality and disturbance with written questionnaire at 24 months post-operative |
| fasting glucose , postprandial glucose | Change from pre-operative in fasting glucose , postprandial glucose at 36 months post-operative. |
| GH suppressive responses (a nadir GH < 0.4 ng/ml) to oral glucose | Change from Pre-operative in GH suppressive responses (a nadir GH < 0.4 ng/ml) at 36 months post-operative |
| HbA1c | change from pre-operative in HbA1c at 36 months post-operative. |
| insulin | Change from pre-operative in insulin at 36 months post-operative. |
| Clinical symptom and sign with AcroQoL questionnaire | Change from Pre-operative in Clinical symptom and sign with AcroQoL questionnaire at 36 months post-operative |
Countries
South Korea
Contacts
Primary Contactminseon Kim, PhD
Backup Contactheesun Park, college
Outcome results
None listed