Growth Hormone Use in Adults With Prader-Willi Syndrome

Status Completed

Clinical Trial Summary

Clinical Trial Description

The main research question this protocol aims to answer is whether treatment with growth hormone will impact body composition, quality of life, and energy balance in PWS adults, and if there is a loss of effects after cessation of treatment for at least 12 months. Specific outcomes to be evaluated are as follows: • Increased IGF-1 as a function of human growth hormone dosage compared with baseline. 1. Improvement of indicators or risk factors for co-morbid diseases [diabetes (by measuring insulin and glucose levels), cardiovascular disease (by measuring lipids and fatty acids), and pulmonary function] in participants. 2. Improvement in quality of life measures as indicated by ratings on established behavior checklists in participants. 3. Changes in body composition (decreased fat, increased lean body mass and bone density) as determined by DEXA in participants. 4. Increased energy expenditure as determined by whole-room calorimeter measures (8 hour energy expenditure, RMR, TEF, mechanical work); diet records, physical activity monitors and strength measures. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00444964
Study type	Interventional
Source	Children's Mercy Hospital Kansas City
Contact
Status	Completed
Phase	Phase 3
Start date	April 2005
Completion date	January 1, 2012

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05032326` - Long-term Interventional Follow-up Study of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical Trial	Phase 3
Completed	`NCT04526379` - Study of Emotion and Cognition Abilities of Children With PWS and Proposition of an Innovative Remediation	N/A
Terminated	`NCT03458416` - A Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Participants With Prader-Willi Syndrome	Phase 2
Completed	`NCT03718416` - Natural History Study of Serious Medical Events in PWS
Completed	`NCT05322096` - Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome	Phase 2
Completed	`NCT02205450` - Growth Hormone in Children Under 2 Years With Prader-Willi in Hospital of Sabadell
Terminated	`NCT02179151` - Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome	Phase 3
Completed	`NCT00375089` - Characteristics of Prader-Willi Syndrome and Early-onset Morbid Obesity	N/A
Completed	`NCT00004351` - Study of Phenotype and Genotype Correlations in Patients With Contiguous Gene Deletion Syndromes	N/A
Recruiting	`NCT05938543` - Cerebellar TMS and Satiety in Prader-Willi Syndrome	N/A
Suspended	`NCT05879614` - An Open-Label Study of Oral NNZ-2591 in Prader-Willi Syndrome (PWS-001)	Phase 2
Recruiting	`NCT03031626` - Oxygen Versus Medical Air for Treatment of CSA in Prader Will Syndrome	Phase 4
Withdrawn	`NCT04086810` - An Open-Label Study of DCCR Tablet in Patients With PWS	Phase 3
Completed	`NCT02629991` - Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome	Phase 2
Recruiting	`NCT02297022` - Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome	Phase 1
Not yet recruiting	`NCT02263781` - PREPL in Health and Disease	N/A
Completed	`NCT00551343` - Gut Derived Hormones, Body Composition and Metabolism in Prader-Willi Syndrome	N/A
Recruiting	`NCT06448871` - Ultrasound to Assess Sarcopenia in Prader Willi Syndrome
Enrolling by invitation	`NCT03655223` - Early Check: Expanded Screening in Newborns
Recruiting	`NCT05939453` - Impact of Bright Light Therapy on Prader-Willi Syndrome	N/A