Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novartis Korea Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 2: Surgery + Medical treatment | Experimental | MRI : residual tumor 6 months post-op : IGF-1 >600 ng/ml medical treatment : Sandostatin (Octreotide Acetate) |
|
| Group 3 : Rescue group | No Intervention | If IGF-1 levels fails to normalize till post-op 18 months post-op, medical treatment will be added.) | |
| Gruop1 : Surgery only group | No Intervention | MRI : without residual tumor 6months post-operation and IGF-1 <600ng/ml |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sandostatin (Octreotide Acetate) | Drug | For the patients outlined above (refer to 2), subjects who are not able to be treated by surgery alone:
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Clinical symptom and sign with AcroQoL questionnaire | Change from Pre-operative in Clinical symptom and sign with AcroQoL questionnaire at 36 months post-operative |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| minseon Kim, PhD | Contact | 82-2-3010-3245 | mskim@amc.seoul.kr | |
| heesun Park, college | Contact | 82-2-3010-4135 | guccienvy2@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| minseon Kim, PhD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | 138-736 | South Korea |
Not provided
| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
Not provided
Not provided
| ID | Term |
|---|---|
| D015282 | Octreotide |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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. |
| insulin | Change from pre-operative in insulin at 36 months post-operative. |
| HbA1c | change from pre-operative in HbA1c at 36 months post-operative. |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |