An observational study in Central Adrenal Insufficiency and Prader-Willi Syndrome, sponsored by Medical University of Warsaw. Completed at 1 site in Poland. Open to participants aged 18 Years to 26 Years. Per ClinicalTrials.gov, last updated 2021-01-08.
Sponsored by Medical University of Warsaw · Observational
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.
138 studies on the registry are indexed under Prader-Willi Syndrome; 24 are open to participants now.
This study's enrollment of 21 is below the median of 52 across 34 observational studies indexed under Prader-Willi Syndrome.
Browse Prader-Willi Syndrome studies →Medical University of Warsaw is the lead sponsor of 316 studies on the registry; 87 are open to participants now.
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Consecutive patients with PWS, referred to the Department of Endocrinology Medical University of Warsaw.
Exclusion Criteria:
The prevalence of CAI in adult PWS patients based on HDSST.
The diagnosis of CAI was based on the high-dose short Synacthen test (HDSST). The following cut-off points were used: 1. CAI group (suspected CAI): • cortisol \< 500 nmol/L at the 30th minute 2. AS group (adrenal sufficiency - CAI excluded): • cortisol ≥ 600 nmol/L at the 30th minute 3. Intermediate group • cortisol ≥500 nmol/L and \<600 nmol/L at the 30th minute
Time frame: At first visit (before HCT treatment).
Symptoms of CAI before hydrocortisone substitution: fatigue
Incidence of the fatigue in the CAI, intermediate and the AS groups.
Time frame: Before HCT treatment
Symptoms of CAI after 6 month hydrocorisone treatment: fatigue
Incidence of the fatigue in the CAI, intermediate and the AS groups.
Time frame: After 6 month HCT treatment
Symptoms of CAI after 12 month hydrocorisone treatment: fatigue
Incidence of the fatigue in the CAI, intermediate and the AS groups.
Time frame: After 12 month HCT treatment
Symptoms of CAI before hydrocortisone substitution: loss of appetite
Incidence of loss of appetite in the CAI, intermediate and the AS groups.
Time frame: Before HCT treatment
Symptoms of CAI after 6 month hydrocorisone treatment: loss of appetite
Incidence of loss of appetite in the CAI, intermediate and the AS groups.
Time frame: After 6 month HCT treatment
Symptoms of CAI after 12 month hydrocorisone treatment: loss of appetite
Incidence of loss of appetite in the CAI, intermediate and the AS groups.
Time frame: After 12 month HCT treatment
Symptoms of CAI before hydrocortisone substitution: muscle weakness
Incidence of the muscle weakness in the CAI, intermediate and the AS groups.
Time frame: Before HCT treatment
Symptoms of CAI after 6 month hydrocortisone treatment: muscle weakness
Incidence of the muscle weakness in the CAI, intermediate and the AS groups.
Time frame: After 6 month HCT treatment
Symptoms of CAI after 12 month hydrocortisone treatment: muscle weakness
Incidence of the muscle weakness in the CAI, intermediate and the AS groups.
Time frame: After 12 month HCT treatment
Symptoms of CAI before hydrocortisone substitution: myalgia
Incidence of the myalgia in the CAI, intermediate and the AS groups.
Time frame: Before HCT treatment
Symptoms of CAI after 6 month hydrocorisone treatment: myalgia
Incidence of the myalgia in the CAI, intermediate and the AS groups.
Time frame: After 6 month HCT treatment
Symptoms of CAI after 12 month hydrocorisone treatment: myalgia
Incidence of the myalgia in the CAI, intermediate and the AS groups.
Time frame: After 12 month HCT treatment
Symptoms of CAI before hydrocortisone substitution: arthralgia
Incidence of the arthralgia in the CAI, intermediate and the AS groups.
Time frame: Before HCT treatment
Symptoms of CAI after 6 month hydrocorisone treatment: arthralgia
Incidence of the arthralgia in the CAI, intermediate and the AS groups.
Time frame: After 6 month HCT treatment
Symptoms of CAI after 12 month hydrocorisone treatment: arthralgia
Incidence of the arthralgia in the CAI, intermediate and the AS groups.
Time frame: After 12 month HCT treatment
Symptoms of CAI before hydrocortisone substitution: weight loss
Incidence of the weight loss (\>3 kg) in the CAI, intermediate and the AS groups.
Time frame: Before HCT treatment
Symptoms of CAI after 6 month hydrocorisone treatment: weight loss
Incidence of the weight loss (\>3 kg) in the CAI, intermediate and the AS groups.
Time frame: After 6 month HCT treatment
Symptoms of CAI after 12 month hydrocorisone treatment: weight loss
Incidence of the weight loss (\>3 kg) in the CAI, intermediate and the AS groups.
Time frame: After 12 month HCT treatment
Symptoms of CAI before hydrocortisone substitution: nausea
Incidence of the nausea in the CAI, intermediate and the AS groups.
Time frame: Before HCT treatment
Symptoms of CAI after 6 month hydrocorisone treatment: nausea
Incidence of the nausea in the CAI, intermediate and the AS groups.
Time frame: After 6 month HCT treatment
Symptoms of CAI after 12 month hydrocorisone treatment: nausea
Incidence of the nausea in the CAI, intermediate and the AS groups.
Time frame: After 12 month HCT treatment
Symptoms of CAI before hydrocortisone substitution: vomiting
Incidence of the vomiting in the CAI, intermediate and the AS groups.
Time frame: Before HCT treatment
Symptoms of CAI after 6 month hydrocorisone treatment: vomiting
Incidence of the vomiting in the CAI, intermediate and the AS groups.
Time frame: After 6 month HCT treatment
Symptoms of CAI after 12 month hydrocorisone treatment: vomiting
Incidence of the vomiting in the CAI, intermediate and the AS groups.
Time frame: After 12 month HCT treatment
Symptoms of CAI before hydrocortisone substitution: abdominal pain
Incidence of the abdominal pain in the CAI, intermediate and the AS groups.
Time frame: Before HCT treatment
Symptoms of CAI after 6 month hydrocorisone treatment: abdominal pain
Incidence of the abdominal pain in the CAI, intermediate and the AS groups.
Time frame: After 6 month HCT treatment
Symptoms of CAI after 12 month hydrocorisone treatment: abdominal pain
Incidence of the abdominal pain in the CAI, intermediate and the AS groups.
Time frame: After 12 month HCT treatment
BMI before hydrocortisone substitution in PWS patients with CAI
Measurement of weight and height will be combined to report BMI in kg/m\^2.
Time frame: Before HCT treatment
BMI after 6 month hydrocortisone substitution in PWS patients with CAI
Measurement of weight and height will be combined to report BMI in kg/m\^2.
Time frame: After 6 month HCT treatment
BMI after 12 month hydrocortisone substitution in PWS patients with CAI
Measurement of weight and height will be combined to report BMI in kg/m\^2.
Time frame: After 12 month HCT treatment
Body fat percentage before hydrocortisone substitution in PWS patients with CAI
Measurement of the body fat percentage using bioelectrical impedance method.
Time frame: Before HCT treatment
Body fat percentage after 6 month hydrocortisone substitution in PWS patients with CAI
Measurement of the body fat percentage using bioelectrical impedance method.
Time frame: After 6 month HCT treatment
Body fat percentage after 12 month hydrocortisone substitution in PWS patients with CAI
Measurement of the body fat percentage using bioelectrical impedance method.
Time frame: After 12 month HCT treatment
Concentration of morning cortisol
Results of morning cortisol in the entire study group.
Time frame: At first visit (before HCT treatment).
Concentration of ACTH
Results of ACTH in the entire study group.
Time frame: At first visit (before HCT treatment).
Concentration of dihydroepiandrosterone sulfate
Results of dihydroepiandrosterone sulfate measurements in the entire study group.
Time frame: At first visit (before HCT treatment).
Laboratory findings - short Synacthen test
Results of the short Synacthen test in the entire study group.
Time frame: At first visit (before HCT treatment).
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Medical University of Warsaw