NCT04700644

Assessment of CAI in Adults With PWS.

Assessment of Central Adrenal Insufficiency in Adults With Prader-Willi Syndrome.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 21 (actual)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years – 26 Years
• Healthy volunteers: Not accepted

Summary

Introduction: The prevalence and clinical significance of central adrenal insufficiency (CAI) in adult patients with Prader Willi Syndrome (PWS) remains unclear. Aim: To assess the prevalence of CAI in adults with PWS and to analyse the effects of replacement therapy with hydrocortisone (HCT) in patients with suspected CAI. Material and Methods: Twenty one adult patients with PWS were evaluated. Based on peak cortisol at the 30 minute of the high dose short Synacthen test (HDSST), patients were divided into three groups: CAI (central adrenal insufficiency) - peak cortisol \<500nmol/L, intermediate (partial AI) - peak cortisol ≥500 nmol/L and \<600 nmol/L and AS (adrenal sufficiency) - peak cortisol ≥ 600 nmol/L. In patients with diagnosed CAI HCT replacement treatment was initiated. Body weight, body fat percentage, signs, and symptoms of CAI were evaluated after 6 and 12 months of treatment.

Conditions

• Central Adrenal Insufficiency
• Prader-Willi Syndrome

Timeline

• Start date: 2020-05-15
• Primary completion: 2020-06-06
• Completion: 2020-06-06
• First posted: 2021-01-08
• Last updated: 2021-01-08

Locations

1 site across 1 country: Poland