Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06313164
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2024-03-10
Brief Title:
The Impact of Oral Glutathione on Oxidative Damage and Glycated Hemoglobin HbA1c Levels in Type 2 Diabetes Patients
Sponsor:
SLAB SOLOWAYS
Organization:
SLAB SOLOWAYS
Study Overview
Official Title:
The Impact of Oral Glutathione on Oxidative Damage and Glycated Hemoglobin HbA1c Levels in Type 2 Diabetes Patients A Randomized Double-Blind Placebo-Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial aims to assess the effectiveness of L-glutathione supplemented with bioavailability boosters tannin low molecular weight chitosan and polyethylene glycol on improving antioxidant levels and glycemic control in patients with type 2 diabetes T2D The study is designed as a randomized double-blind placebo-controlled trial intending to enroll 240 T2D patients The primary objective is to measure changes from baseline to 180 days in several key biomarkers including endogenous reduced glutathione GSH oxidized glutathione GSSG 8-hydroxydeoxyguanosine 8-OHdG and glycated hemoglobin HbA1c along with other metabolic parameters
Hypothesis The anticipated outcome is a significant increase in GSH levels and a decrease in markers of oxidative damage among participants receiving L-glutathione compared to those in the placebo group potentially indicating improved antioxidant defenses and some effects on glycemic regulation in T2D patients This trial aims to fill gaps in current research regarding the role of L-glutathione supplementation in managing oxidative stress and metabolic control in diabetes
Hypothesis The anticipated outcome is a significant increase in GSH levels and a decrease in markers of oxidative damage among participants receiving L-glutathione compared to those in the placebo group potentially indicating improved antioxidant defenses and some effects on glycemic regulation in T2D patients This trial aims to fill gaps in current research regarding the role of L-glutathione supplementation in managing oxidative stress and metabolic control in diabetes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None