NCT04375020

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
Last Updated

May 7, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

May 2, 2020

Last Update Submit

May 5, 2020

Conditions

Diabetes Mellitus, Type 1

Keywords

type 1diabetes, gaba

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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

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.

Interventions

GABADRUG

GABA nutritional supplement 750mg per day for 6 months

group1 on GABA

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • thyroid problems liver disease kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahmoud Younis

Cairo, 11865, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

gamma-Aminobutyric Acid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
consultant

Study Record Dates

First Submitted

May 2, 2020

First Posted

May 5, 2020

Study Start

November 1, 2019

Primary Completion

May 1, 2020

Study Completion

May 2, 2020

Last Updated

May 7, 2020

Record last verified: 2020-05

Locations

EG(1)