| CTRI Number |
CTRI/2018/01/011257 [Registered on: 10/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
16/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Antioxidant supplement] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Will glutathione supplementation help glucose control in diabetic patients? |
|
Scientific Title of Study
|
A Study of Glutathione on Glucose Homeostasis in type 2 Diabetes Mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saroj Ghaskadbi |
| Designation |
Professor |
| Affiliation |
Savitribai Phule Pune University |
| Address |
Department of Zoology, Savitribai Phule Pune University,
Ganeshkhind Road, Pune
Pune
MAHARASHTRA
411007
Pune
MAHARASHTRA
411007
India |
| Phone |
9850993508 |
| Fax |
020-25690617 |
| Email |
ssg@unipune.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Saroj Ghaskadbi |
| Designation |
Professor |
| Affiliation |
Savitribai Phule Pune University |
| Address |
Department of Zoology, Savitribai Phule Pune University,
Ganeshkhind Road, Pune
Pune
MAHARASHTRA
411007
Pune
MAHARASHTRA
411007
India |
| Phone |
9850993508 |
| Fax |
020-25690617 |
| Email |
ssg@unipune.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Saroj Ghaskadbi |
| Designation |
Professor |
| Affiliation |
Savitribai Phule Pune University |
| Address |
Department of Zoology, Savitribai Phule Pune University,
Ganeshkhind Road,
Pune-411007
MAHARASHTRA
411007
Savitribai Phule Pune University,
Ganeshkhind Road,
Pune-411007
MAHARASHTRA
Pune
MAHARASHTRA
411007
India |
| Phone |
9850993508 |
| Fax |
020-25690617 |
| Email |
ssg@unipune.ac.in |
|
|
Source of Monetary or Material Support
|
| Monetary support is provided by Savitribai Phule Pune University, Ganeshkhind Road,Pune-411007. |
|
|
Primary Sponsor
|
| Name |
Savitribai Phule Pune University |
| Address |
Ganeshkhind Road, Pune 411007.
Maharashtra,
India. |
| Type of Sponsor |
Other [University] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijay Gajjar |
Jehangir Hospital |
Jehangir Clinical Development Center
Jehangir Hospital Premises
32 Sassoon Road Pune 411001
Pune
MAHARASHTRA |
9586864542
vijaygajjar2008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Jehangir Clinical Development Centre Pvt Ltd |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Those, with HbA1c more than or equal to 6.5%
and fasting glucose more than or equal to 126
mg/dl are included, (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Glutathione |
Individuals are included in one
of the three groups 1. Control
healthy nondiabetic 2. Diabetic
without glutathione
supplementation 3. Diabetic
with glutathione
supplementation |
| Comparator Agent |
Not Applicable |
There is no comparator agent in this study. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Does glutathione supplementation over 6 months
result in at least 10% increase in blood GSH
levels?
Does GSH supplementation aid in lowering
fasting and post prandial glucose concentrations
in diabetics due to anti-diabetic therapy and also
HbA1c by an additional 0.1mmol/L? |
0, 3, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Whether SNPs in glutathione synthase gene
have any effect on its basal concentrations found
in blood? |
3 month |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "360"
Final Enrollment numbers achieved (India)="360" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/02/2016 |
| Date of Study Completion (India) |
19/01/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |