Diabetes Mellitus, Type 1NCT04375020
GABA and Beta-cell Regeneration
An observational study of Diabetes Mellitus, Type 1, run by Ministry of Health and Population, Egypt at 1 site in Egypt.
Trial summary
GABA(gamma-Aminobutyric acid) may be used for decreasing anti-gad antibodies and leads beta-cell regeneration. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- GABA
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2019to 2 May 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Adult
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.
Who may be able to join
- type 1 diabetes patients age from 18 to 25 years on basal bolus insulin
Who cannot join
- thyroid problems liver disease kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- GABA
- Keywords
- type 1diabetes, gaba
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GABADrug
GABA nutritional supplement 750mg per day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
gaba decrease anti gad antibodies
gaba 750 mg daily for type 1 diabetes patients
Measured: 6 months
gaba improve c peptide levels
gaba 750 mg pe day for type 1 diabetes patients
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Nov 2019
- Primary completion1 May 2020
- Study completion2 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ministry of Health and Population, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, mahmoud younis, Ministry of Health and Population, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375020
- Sponsor's protocol ID
- icel
- Status last verified
- May 2020
- First submitted
- 2 May 2020
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GABA From Medical Nutrition to Pancreatic Beta-cell Regeneration
- ClinicalTrials.gov ID
- NCT04375020
- Acronym / sponsor ID
- icel
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- type 1diabetes, gaba
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ministry of Health and Population, EgyptOther government
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 2 May 2020 (actual)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group1 on GABA | – | Drug: GABAThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- type 1 diabetes patients age from 18 to 25 years on basal bolus insulin
Key exclusion criteria (1 listed)
- thyroid problems liver disease kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GABAGABA nutritional supplement 750mg per day for 6 months | Drug | group1 on GABA |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by Ministry of Health and Population, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gaba decrease anti gad antibodies (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.