Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT04375020
Status:
COMPLETED
Last Update Posted:
2020-05-07
First Post:
2020-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GABA and Beta-cell Regeneration
Sponsor:
Ministry of Health and Population, Egypt
Organization:
Study Overview
Official Title:
GABA From Medical Nutrition to Pancreatic Beta-cell Regeneration
Status:
COMPLETED
Status Verified Date:
2020-05
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:
GABA(gamma-Aminobutyric acid) may be used for decreasing anti-gad antibodies and leads beta-cell regeneration.
Detailed Description:
100 patients with type I diabetes were in 2 groups, had been monitored in a private clinic, number 50 each group, with 30 females and 20 males after the written consent of all patients.
All the patients Lied between 18-25 years old with 5-10 years of diabetes onset.
The first group was on insulin therapy in the form of toujeo once daily and Novorapid 3 times daily and they received GABA nutritional supplement 750mg per day.
The second group was only on insulin injection in the form of toujeo once daily and Novorapid 3 times daily.
In the first group;the investigator measured fasting c peptide levels before and after 6 months of GABA 750mg daily.Also,the investigator measured anti gad antibodies before and after 6 months of treatment.
In the second group,the investigator measured c peptide levels and anti-gad antibodies at the beginning of the trial and after 6 months.
All the patients Lied between 18-25 years old with 5-10 years of diabetes onset.
The first group was on insulin therapy in the form of toujeo once daily and Novorapid 3 times daily and they received GABA nutritional supplement 750mg per day.
The second group was only on insulin injection in the form of toujeo once daily and Novorapid 3 times daily.
In the first group;the investigator measured fasting c peptide levels before and after 6 months of GABA 750mg daily.Also,the investigator measured anti gad antibodies before and after 6 months of treatment.
In the second group,the investigator measured c peptide levels and anti-gad antibodies at the beginning of the trial and after 6 months.
Study Oversight
Has Oversight DMC:
False
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?: