GABA and Beta-cell Regeneration

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

GABA From Medical Nutrition to Pancreatic Beta-cell Regeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04375020
• Other study ID #: icel
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: May 2, 2020

Study information

• Verified date: May 2020
• Source: Ministry of Health and Population, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

GABA(gamma-Aminobutyric acid) may be used for decreasing anti-gad antibodies and leads beta-cell regeneration.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2, 2020
• Est. primary completion date: May 1, 2020
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• type 1 diabetes patients age from 18 to 25 years on basal bolus insulin

Exclusion Criteria:

thyroid problems liver disease kidney disease

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Drug:
• GABA
GABA nutritional supplement 750mg per day for 6 months

Locations

Country	Name	City	State
Egypt	Mahmoud Younis	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health and Population, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gaba decrease anti gad antibodies	gaba 750 mg daily for type 1 diabetes patients	6 months
Primary	gaba improve c peptide levels	gaba 750 mg pe day for type 1 diabetes patients	6 months