Glutathione and Function in HIV Patients
Primary Purpose
HIV Infection, Erythrocyte Glutathione Deficiency
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GlyNAC (combination of glycine and n-acetylcysteine)
Sponsored by
About this trial
This is an interventional other trial for HIV Infection
Eligibility Criteria
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.
Sites / Locations
- Baylor Metabolic Research Unit (MRU)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GlyNAC
Arm Description
HIV infected subjects will be studied before and after taking oral glycine and n-acetylcysteine for 3 months
Outcomes
Primary Outcome Measures
Muscle Glutathione Concentration
Muscle glutathione concentrations measured by liquid chromatography
Secondary Outcome Measures
Full Information
NCT ID
NCT02348775
First Posted
January 15, 2015
Last Updated
February 2, 2021
Sponsor
Baylor College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02348775
Brief Title
Glutathione and Function in HIV Patients
Official Title
Glutathione and Function in HIV Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
August 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Erythrocyte Glutathione Deficiency
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GlyNAC
Arm Type
Experimental
Arm Description
HIV infected subjects will be studied before and after taking oral glycine and n-acetylcysteine for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
GlyNAC (combination of glycine and n-acetylcysteine)
Intervention Description
HIV patients will be studied before and after receiving GlyNAC
Primary Outcome Measure Information:
Title
Muscle Glutathione Concentration
Description
Muscle glutathione concentrations measured by liquid chromatography
Time Frame
20-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R V Sekhar, M.D.
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor Metabolic Research Unit (MRU)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from the study will be submitted for publication once analyses are completed
Learn more about this trial
Glutathione and Function in HIV Patients
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