Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-24 @ 1:28 PM
NCT ID:
NCT02084095
Eligibility Criteria:
Inclusion Criteria:
* active acromegaly based on following criteria: minimum GH in oral glucose tolerance test (OGTT) over 1 ng/mL and serum IGF-I over upper limit of normal for age and sex
* age between 18 and 65 years old
Exclusion Criteria:
* more than one previous pituitary surgical intervention for acromegaly
* present medical treatment for acromegaly (somatostatin analogs, GH-receptor blockers, dopaminergic agonists)
* previous pituitary radiotherapy
* present medical treatment for hyperglycemia (oral antidiabetic drugs, insulin, etc)
* pituitary failure, treated or not
* medical or surgical conditions which, in the oppinion of the principal investigator, could impact on study results or patient's safety
* fasting blood glucose over 200 mg/dL or HbA1c over 8%.
* body mass index less than 20 or over 35 kg/mp
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02084095
Study Brief:
Protocol Section:
NCT02084095