GABA and Beta-cell Regeneration

GABA From Medical Nutrition to Pancreatic Beta-cell Regeneration

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: GABA

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11865
    • Mahmoud Younis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

observation prospective study 100 patients with type I diabetes were int 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

thyroid problems liver disease kidney disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group1 on GABA; 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.	Drug: GABA; GABA nutritional supplement 750mg per day for 6 months
group 2 on just insulin; The second group was only on insulin injection in the form of toujeo once daily and Novorapid 3 times daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gaba decrease anti gad antibodies	gaba 750 mg daily for type 1 diabetes patients	6 months
gaba improve c peptide levels	gaba 750 mg pe day for type 1 diabetes patients	6 months

Collaborators and Investigators

• Sponsor: Ministry of Health and Population, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 2, 2020

Study Registration Dates

• First Submitted: May 2, 2020
• First Submitted That Met QC Criteria: May 2, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 5, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: type 1diabetes, gaba
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: icel

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No