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NCT01384591 · ClinicalTrials.gov registry record · Phase 1
Pilot Study of Losartan and N-acetylcysteine as Inhibitors of Muscle Oxidative Stress in Elderly
A Phase 1 study, sponsored by The University of Texas Medical Branch, Galveston.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01384591 is a Phase 1 study that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 6 participants.
The verdict
NCT01384591, a Phase 1 study, has completed, sponsored by The University of Texas Medical Branch, Galveston.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The general hypothesis is that elderly have diminished nutritive flow to skeletal muscle and impaired capacity for building muscle. In aging populations, this decreased ability to build muscle may represent a tipping point in the progression towards chronic physical frailty and disability. The goal is to examine whether novel pharmacologic therapies can improve nutritive blood flow to the muscles and muscle building in the elderly. The purpose of this study is 1) to determine if losartan administration will enhance blood flow and 2) to determine if N-acetylcysteine (NAC) will enhance blood flow. The investigators will study community dwelling, healthy older men and women (60-85 years). Subjects will be randomized to one of three groups: Experimental Group 1: Placebo losartan and placebo N-acetylcysteine (NAC). Experimental Group 2: losartan (25mg/dose) and placebo N-acetylcysteine (NAC). Experimental Group 3: N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo Subjects will admit to the clinic on day 1 of the study. Baseline testing consisting of leg blood flow (LBF), contrast enhanced ultrasound, handgrip testing and fatigue questionnaires. After testing is completed the subjects will recieve their first dose of NAC/ losartan/ placebo with dinner. Subjects will be fasted after 10 pm. On day 2, leg blood flow (LBF) will be measured approximately 12 hours post dose 1. Subjects will receive their second dose of NAC/ losartan/ placebo. Leg blood flow will be measured 1 hour and 2 hours post dose 2 of study interventions. The subjects will eat a meal and receive their third dose of the study intervention. Leg blood flow will be repeated at 1 hour and 2 hours post dose 3. Appoximately 30 minutes after dose 3 of the study intervention, handgrip testing will be performed and fatigue questionnaires completed.
Interventions
- DRUG Losartan
- DRUG N-acetylcysteine
- DRUG Placebo losartan
- DRUG Placebo N-acetylcysteine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2011-07 |
| Est. Completion | 2015-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01384591
The ClinicalTrials.gov registry entry for NCT01384591 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Medical Branch, Galveston, which has 203 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Losartan is the first listed.
NCT01384591 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01384591 about?
NCT01384591 is a clinical study titled "Pilot Study of Losartan and N-acetylcysteine as Inhibitors of Muscle Oxidative Stress in Elderly". The general hypothesis is that elderly have diminished nutritive flow to skeletal muscle and impaired capacity for building muscle. In aging populations, this decreased ability to build muscle may represent a tipping point in the progression towards chronic physical frailty and disability. The goal ...
What is the current status of trial NCT01384591?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2011-07. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01384591?
The interventions under investigation include: Losartan (DRUG), N-acetylcysteine (DRUG), Placebo losartan (DRUG), Placebo N-acetylcysteine (DRUG).
Who is sponsoring clinical trial NCT01384591?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
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