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NCT01355198 · ClinicalTrials.gov registry record · Phase 1
Role of HIV on Glutathione Synthesis and Oxidative Stress
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT01355198 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 10 participants.
The verdict
NCT01355198, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
HIV infection is associated the development of increased oxidative stress and deficiency of glutathione (GSH), the dominant endogenous antioxidant protein, but the underlying mechanisms contributing to GSH deficiency are hitherto unknown. Furthermore GSH metabolism has not been studied in HIV patients, in whom the burden of risk factors promoting oxidative stress is highest. Our previous studies in non-HIV human subjects with diabetes-related oxidative stress and GSH deficiency have demonstrated that the latter is due to decreased synthesis of GSH. Importantly, short-term dietary supplementation with the simple GSH precursor amino-acids cysteine and glycine, boosted GSH synthesis and cellular concentrations, corrected GSH deficiency, and reduced oxidative stress and oxidant damage. The current proposal will study whether (1) defective synthesis underlies GSH deficiency in patients with HIV, and will test a simple, inexpensive and rational therapy based on protein supplementation to improve GSH synthesis and concentrations and lower markers of oxidative stress and oxidant damage in these patients; (2) study if correction of GSH deficiency is asssociated with any changes in (a) impaired mitochondrial fuel oxidation in the fasted and insulin stimulated states; (b) insulin sensitivity; (c) body composition and anthropometry; (d) forearm muscle strength; (e) plasma biochemistry, and (f) quality of life indices in these subjects.
Interventions
- DIETARY_SUPPLEMENT Cysteine (as n-acetylcysteine) and glycine
- DIETARY_SUPPLEMENT Cysteine/glycine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2010-08 |
| Est. Completion | 2011-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01355198
The ClinicalTrials.gov registry entry for NCT01355198 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cysteine (as n-acetylcysteine) and glycine is the first listed.
NCT01355198 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01355198 about?
NCT01355198 is a clinical study titled "Role of HIV on Glutathione Synthesis and Oxidative Stress". HIV infection is associated the development of increased oxidative stress and deficiency of glutathione (GSH), the dominant endogenous antioxidant protein, but the underlying mechanisms contributing to GSH deficiency are hitherto unknown. Furthermore GSH metabolism has not been studied in HIV patien...
What is the current status of trial NCT01355198?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2010-08. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01355198?
The interventions under investigation include: Cysteine (as n-acetylcysteine) and glycine (DIETARY_SUPPLEMENT), Cysteine/glycine (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01355198?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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