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NCT02124057 · ClinicalTrials.gov registry record
Study of Hepatic Function in Patients With Spinal and Bulbar Muscular Atrophy
A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 71
- Enrollment target
NCT02124057: Completed study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT02124057 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 71 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02124057 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 71 participants
- Enrollment target
Study Summary
Background: \- Spinal and bulbar muscular atrophy (SBMA) is an inherited disease. It causes weakness in muscles used for swallowing, breathing, and speaking. SBMA mainly affects men, but women can carry the gene for it. Researchers think there may be a link between SBMA and excess fat in the liver. Objective: \- To look for fatty liver and liver injury in people with SBMA, people with motor neuron disease, and people who carry the gene for SBMA. Eligibility: * Adults 18 years and older who have SBMA, have motor neuron disease, or are carriers of SBMA. * Healthy adult volunteers. Design: * Participants will be screened with medical history, physical exam, and blood tests. * Participants will have 1 outpatient visit of 1-2 days. Women will have a urine pregnancy test. All participants will have: * Blood tests. * Liver ultrasound. A probe is placed on the abdomen at certain locations and angles and takes pictures. The painless procedure takes 20-30 minutes. * Liver magnetic resonance imaging (MRI) scan. The MRI scanner is a metal cylinder with a magnetic field. Participants will lie on a table that slides in and out of it. They will be in the scanner for about 30 minutes. They will get earplugs for loud noises. * Some participants with abnormal liver testing will have a biopsy (small piece) of the liver taken. The biopsy site will be located with ultrasound, then cleaned and numbed. The physician will quickly pass a needle in and out of the liver while the participants holds their breath. Afterward, participants will be monitored in bed for 6 hours. * Participants may return for follow-up and another 1-2 day outpatient visit yearly for up to 2 years.
Primary Outcome
The primary outcome measures will be the liver fat deposition measured by liver MRS proton density fat fraction at the site of the dome of the liver. These measures will help us evaluate the prevalence and severity of fatty liver infiltration in SBMA patients compared to healthy controls.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2014-08-04 |
| Est. Completion | 2020-11-19 |
What the finished NCT02124057 record still lists
NCT02124057 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 71 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02124057 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02124057 about?
NCT02124057 is a clinical study titled "Study of Hepatic Function in Patients With Spinal and Bulbar Muscular Atrophy". Background: \- Spinal and bulbar muscular atrophy (SBMA) is an inherited disease. It causes weakness in muscles used for swallowing, breathing, and speaking. SBMA mainly affects men, but women can carry the gene for it. Researchers think there may be a link between SBMA and excess fat in the liver....
What is the current status of trial NCT02124057?
This trial is currently completed. The enrollment target is 71 participants. The study started on 2014-08-04. Estimated completion is 2020-11-19.
Who is sponsoring clinical trial NCT02124057?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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