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Clinical Trials/NCT04375020
NCT04375020CompletedNot Applicable

GABA From Medical Nutrition to Pancreatic Beta-cell Regeneration

Ministry of Health and Population, Egypt1 site in 1 country100 target enrollmentStarted: November 1, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
gaba decrease anti gad antibodies

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 25 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • thyroid problems liver disease kidney disease

Arms & Interventions

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.

Intervention: GABA (Drug)

Outcomes

Primary Outcomes

gaba decrease anti gad antibodies

Time Frame: 6 months

gaba 750 mg daily for type 1 diabetes patients

gaba improve c peptide levels

Time Frame: 6 months

gaba 750 mg pe day for type 1 diabetes patients

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Ministry of Health and Population, Egypt
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

mahmoud younis

consultant

Ministry of Health and Population, Egypt

Study Sites (1)

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