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 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
NCT ID:
NCT07143266
Eligibility Criteria:
Inclusion Criteria:
* Patients with hypothalamic-pituitary dysfunction (HPD) with at least one pituitary hormone deficiency and at least one clinical sign of hypothalamic damage (e.g., arginine-vasopressin deficiency (AVP-D) and/or severe obesity and/or hyperphagia; MRI suggestive of hypothalamic damage; traumatic brain injury; radiotherapy in the sellar region and/or brain tumors affecting the hypothalamus).
* Healthy controls matched for BMI, age, and sex.
Exclusion Criteria:
* Poor control of hormonal deficiencies in the previous 6 months.
* Use of new psychoactive drugs in the last 3 months or occasional use.
* Clinically significant liver, lung, kidney, and cardiovascular disease.
* Any neurological condition affecting brain function (stroke, dementia, uncontrolled epilepsy with recent seizures).
* Uncontrolled diabetes mellitus.
* Active psychosis.
* Ophthalmology: total blindness, Glaucoma, uveitis, visual acuity \<0.6, or eye surgery in the previous 6 months.
* Any acute illness that the investigator determines may interfere with study participation or safety.
* Pregnancy or breastfeeding.
* Patients who refuse or are unable to provide written informed consent.
* In controls: presence of brain or pituitary tumor, radiation involving the hypothalamus or pituitary, and history of hypopituitarism.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07143266
Study Brief:
Protocol Section:
NCT07143266