Clinical trial NCT02427295: Hormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues
Official title: Long-term (up to 3 Years) Clinical and Hormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues: Open-labeled, Prospective, Parallel Group Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acromegaly
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Novartis Korea Ltd.
First posted: 2015-04-28
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients who achieved normalization of fasting serum IGF-1 (age and sex matched)
timeFrame: Change from within 3days post-operative in fasting serum IGF-1at 36 months post-operative
measure: The time taken to IGF-1 normalization in each group.
timeFrame: Change from within 3days post-operative in IGF-1 normalization at 36 months post-operative months post-operative
Secondary outcomes:
measure: GH suppressive responses (a nadir GH < 0.4 ng/ml) to oral glucose
timeFrame: Change from Pre-operative in GH suppressive responses (a nadir GH < 0.4 ng/ml) at 36 months post-operative
measure: Clinical symptom and sign with AcroQoL questionnaire
timeFrame: Change from Pre-operative in Clinical symptom and sign with AcroQoL questionnaire at 36 months post-operative
measure: Sleep quality and disturbance with written questionnaire
timeFrame: Change from Pre-operative in Sleep quality and disturbance with written questionnaire at 24 months post-operative
measure: fasting glucose , postprandial glucose
timeFrame: Change from pre-operative in fasting glucose , postprandial glucose at 36 months post-operative.
measure: insulin
timeFrame: Change from pre-operative in insulin at 36 months post-operative.
measure: HbA1c
timeFrame: change from pre-operative in HbA1c at 36 months post-operative.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: minseon Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References: