Will glutathione supplementation help glucose control in diabetic patients?

Completed

Conditions: Type 2 diabetes mellitus without complications,

Registration Number: CTRI/2018/01/011257

Lead Sponsor: Savitribai Phule Pune University

Brief Summary: Reduced glutathione (GSH), a low molecular weight water soluble tripeptide, is an important endogenous intracellular antioxidant required to maintain redox buffer of cell. It is synthesized by glutathione synthase (GS) and utilized by glutathione peroxidase (GPx) and glutaredoxin (GRx) to detoxify free radicals and in the process gets converted to its oxidized disulfide form (GSSG). GSH is in turn regenerated by glutathione reductase (GR). GSH/GSSG ratio maintained by this complex interplay of enzymes regulates the intracellular redox homeostasis. An imbalance in the GSH/GSSG ratio leads to oxidative stress (OS) which has implications in several diseases including diabetes mellitus. The GSH/GSSG couple has also been shown to play important role in modulating glucose homeostasis. Despite the immense literature available emphasising the importance of glutathione in maintaining redox homeostasis, clinical research data evaluating the effect of GSH supplementation in diabetic patients is very scarce. In the proposed study, we plan to provide GSH supplementation in conjunction with anti-hyperglycemic treatment to study its effect on the glucose homeostasis in diabetic patients. Diabetic patients would be provided 500 mg/day dose of GSH for a period of six months in conjunction with anti-hyperglycemic treatment and the extent of recovery from glycemic stress would be monitored every two months. We also intend to analyse SNPs in the coding region of Glutathione synthase to understand whether genotype of an individual contributes to blood glutathione concentration.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 300

Inclusion Criteria

For Control non-diabetic individuals those with HbA1c less than 6.5% and fasting glucose less than 126 mg/dl are included.
For diabetic individuals those with HbA1c more than or equal to 6.5% and fasting glucose more than or equal to 126 mg/dl are included.

Exclusion Criteria

Pregnant women, individuals suffering from infection, inflammation or malignant disease, heart abnormality, those addicted to smoking/or drinking and those receiving antioxidants are excluded from the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Does glutathione supplementation over 6 months	0, 3, 6 months
Does GSH supplementation aid in lowering	0, 3, 6 months
fasting and post prandial glucose concentrations	0, 3, 6 months
in diabetics due to anti-diabetic therapy and also	0, 3, 6 months
HbA1c by an additional 0.1mmol/L?	0, 3, 6 months
result in at least 10% increase in blood GSH	0, 3, 6 months
levels?	0, 3, 6 months

Secondary Outcome Measures

Name	Time	Method
Whether SNPs in glutathione synthase gene	have any effect on its basal concentrations found

Trial Locations

Locations (1): Jehangir Hospital
🇮🇳
Pune, MAHARASHTRA, India
Jehangir Hospital
🇮🇳Pune, MAHARASHTRA, India
Dr Vijay Gajjar
Principal investigator
9586864542
vijaygajjar2008@gmail.com