Glutathione and Function in HIV Patients
This trial is active, not recruiting.
|Conditions||hiv infection, erythrocyte glutathione deficiency|
|Treatment||cysteine (as n-acetylcysteine) and glycine|
|Sponsor||Baylor College of Medicine|
|Start date||November 2014|
|End date||December 2017|
|Trial size||16 participants|
|Trial identifier||NCT02348775, H-34781 HIV-GSH|
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.
|Intervention model||single group assignment|
|Primary purpose||basic science|
Muscle glutathione concentrations measured by liquid chromatography
time frame: 5 months
Male or female participants from 45 years up to 65 years old.
Inclusion Criteria: HIV patients: - age 45-65 years Non-HIV subjects: - age 45-65 years Exclusion Criteria: 1. Hospitalization in the past 3 months 2. Untreated hypothyroidism or hyperthyroidism 3. Known diabetes mellitus, hypercortisolemia, coronary artery disease. 4. Known liver impairment (ALT and AST >2ULN) 5. Renal impairment (Creatinine>1.4) 6. Inability to walk 7. Patients on anticoagulation or antiplatelet therapy. 8. Patient with triglyceride concentrations >500 mg/dl.
|Official title||Glutathione and Function in HIV Patients|
|Principal investigator||R V Sekhar, M.D.|
|Description||Detailed data are not as yet available|
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