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Completed

NCT Number: NCT04375020

GABA and Beta-cell Regeneration

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

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mahmoud Younis

Cairo, 11865, Egypt

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

thyroid problems liver disease kidney disease

Treatment and study plan

GABA

Drug

GABA nutritional supplement 750mg per day for 6 months

Primary outcomes

  1. gaba decrease anti gad antibodies

    Time frame: 6 months

    gaba 750 mg daily for type 1 diabetes patients

  2. gaba improve c peptide levels

    Time frame: 6 months

    gaba 750 mg pe day for type 1 diabetes patients

Sponsors and collaborators

Lead sponsor

Ministry of Health and Population, Egypt

Other Gov

Registry information

Official study title

GABA From Medical Nutrition to Pancreatic Beta-cell Regeneration

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 5, 2020
Registry last updated
May 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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