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NCT01444898 · ClinicalTrials.gov registry record · NA
Effects of Exenatide on Overweight Adolescents With Prader-Willi Syndrome
A NA study of Prader-Willi Syndrome, sponsored by Children's Hospital Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT01444898 is a NA study of Prader-Willi Syndrome that has completed, run by Children's Hospital Los Angeles. The registered enrollment target is 10 participants, below the 70-participant average among 16 other Prader-Willi Syndrome trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01444898, a NA study of Prader-Willi Syndrome, has completed, sponsored by Children's Hospital Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Prader-Willi Syndrome (PWS) is one of the most common genetic causes of obesity. Obesity is a major source of morbidity and mortality in this population. It can lead to sleep apnea, cor pulmonale, diabetes mellitus, and atherosclerosis. PWS has distinct characteristics that set it apart from other forms of obesity including insatiable appetite and food-seeking behavior which can be disruptive to home and school activities, and can cause severe social and psychological turmoil within families. PWS is also associated with unique hormonal abnormalities, most notably hyperghrelinemia. Ghrelin is a gut hormone produced in the stomach that stimulates food intake during a fast. It is hypothesized that the extremely high ghrelin levels in patients with PWS may cause or contribute to their insatiable appetite. Exenatide, a medication used in the treatment of type 2 diabetes mellitus in adults, appears to suppress ghrelin levels and cause weight loss. It was designed to mimic glucagon-like peptide 1 (GLP-1), an incretin hormone that stimulates insulin secretion and delays gastric emptying, among other effects. In the present study, the investigators will investigate the effects of a 6 month trial of exenatide in overweight adolescents with PWS. The investigators will quantify the changes in weight and body composition, as well as subjective measures of appetite, and concentrations of appetite-associated hormones. The investigators hypothesize that exenatide will improve weight, body composition, appetite, and plasma ghrelin levels during the treatment period.
Conditions Studied
Interventions
- DRUG Exenatide
Study Locations (1)
California
- Children's Hospital of Los Angeles - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01444898
The ClinicalTrials.gov registry entry for NCT01444898 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 70-participant average among 16 other Prader-Willi Syndrome trials with a reported enrollment target (86% lower). The listed sponsor is Children's Hospital Los Angeles, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prader-Willi Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Exenatide is the first listed.
NCT01444898 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01444898 about?
NCT01444898 is a clinical study titled "Effects of Exenatide on Overweight Adolescents With Prader-Willi Syndrome". Prader-Willi Syndrome (PWS) is one of the most common genetic causes of obesity. Obesity is a major source of morbidity and mortality in this population. It can lead to sleep apnea, cor pulmonale, diabetes mellitus, and atherosclerosis. PWS has distinct characteristics that set it apart from other f...
What is the current status of trial NCT01444898?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2012-03. Estimated completion is 2013-12.
What conditions does trial NCT01444898 study?
This clinical trial studies the following conditions: Prader-Willi Syndrome.
What interventions are being tested in trial NCT01444898?
The interventions under investigation include: Exenatide (DRUG).
Who is sponsoring clinical trial NCT01444898?
This trial is sponsored by Children's Hospital Los Angeles, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01444898 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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