Glutathione and Function in HIV Patients
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Baylor College of Medicine
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- Muscle Glutathione Concentration
Study Overview
Brief Summary
We have recently reported that older patients with HIV are deficient in glutathione (GSH) due to decreased availability of cysteine and glycine, and that oral supplementation with cysteine (as n-acetylcysteine) and glycine for 2-weeks corrects their own levels, and improves (but does not fully normalize) concentrations of red-cell GSH. We also found that when GSH deficient, subjects had impaired mitochondrial fuel oxidation and this improved with an increase in intracellular GSH concentrations. These older HIV patients also had significant increases in muscle strength with improvement of GSH levels.The current proposal in older HIV patients will investigate study if cysteine and glycine supplementation for a duration of 12 weeks will result in changes in : (a) GSH levels; (b) body composition/anthropometry; (c) strength and function; (d) quality of life; (e) mitochondrial energetics; (f) biochemistry (including dyslipidemia and oxidative stress); (g) protein and glucose metabolism; (h) cognition and memory. After completing supplementation for 3 months, GSH concentrations, strength, function, mitochondrial energetics and neurocognitive tests will be measured for a further 2 months to determine the effects of washout.
Detailed Description
Detailed data are not as yet available
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •HIV patients:
- •age 45-65 years
- •Non-HIV subjects:
- •age 45-65 years
Exclusion Criteria
- •Hospitalization in the past 3 months
- •Untreated hypothyroidism or hyperthyroidism
- •Known diabetes mellitus, hypercortisolemia, coronary artery disease.
- •Known liver impairment (ALT and AST >2ULN)
- •Renal impairment (Creatinine>1.4)
- •Inability to walk
- •Patients on anticoagulation or antiplatelet therapy.
- •Patient with triglyceride concentrations >500 mg/dl.
Outcomes
Primary Outcomes
Muscle Glutathione Concentration
Time Frame: 20-weeks
Muscle glutathione concentrations measured by liquid chromatography
Secondary Outcomes
No secondary outcomes reported
Investigators
Rajagopal V Sekhar
Associate Professor
Baylor College of Medicine
