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Assessment of CAI in Adults With PWS.

NCT04700644 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2021-01-08

No results posted yet for this study

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

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
26 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-15
Primary Completion
2020-06-06
Completion
2020-06-06

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04700644 on ClinicalTrials.gov