Assessment of CAI in Adults With PWS.

NCT ID: NCT04700644

Last Updated: 2021-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-15

Study Completion Date

2020-06-06

Brief Summary

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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.

Detailed Description

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Conditions

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Central Adrenal Insufficiency Prader-Willi Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* PWS
* age \>=18 years

Exclusion Criteria

* age \<18 years
* GC treatment at last 6 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Magda Goralska

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Central Clinical Hospital Medical University of Warsaw

Warsaw, , Poland

Site Status

Countries

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Poland

Other Identifiers

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CAIPWS

Identifier Type: -

Identifier Source: org_study_id

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