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Clinical Trials/NCT02348775
NCT02348775CompletedPhase 1

Glutathione and Function in HIV Patients

Baylor College of Medicine2 sites in 1 country16 target enrollmentStarted: November 2014Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rajagopal V Sekhar

Associate Professor

Baylor College of Medicine

Study Sites (2)

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