GABA Treatment in Subjects With Type 1 Diabetes
GABA-1
A Randomised, Double-blind, Placebo-controlled, Parallel Group, Single-centre Trial of GABA Treatment in Subjects With Type 1 Diabetes
1 other identifier
interventional
30
1 country
1
Brief Summary
test if a food supplementation with GABA can improve insulin production capacity in type 1 diabetes patients by turning alfa cells into beta cells in accordance with mice and cell studies.randomised parallel study with placebo as control
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2018
Shorter than P25 for not_applicable
1 active site
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
October 10, 2018
CompletedFirst Submitted
Initial submission to the registry
October 22, 2018
CompletedFirst Posted
Study publicly available on registry
October 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedOctober 26, 2018
October 1, 2018
7 months
October 22, 2018
October 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
insulin production
c peptide production during meal stimulation
12 weeks
Secondary Outcomes (11)
c peptide response (change from fasting baseline to meal stimulated concentration in blood)
after 12 weeks
c peptide response beta cell
after 12 weeks
glucagon response
after 12 weeks
metabolic parameters
12 weeks
metabolic parameters dose of insulin
12 weeks
- +6 more secondary outcomes
Study Arms (2)
GABA
ACTIVE COMPARATORgamma Amino butyric acid (GABA) food supplement with 6 g per day
PLACEBO
PLACEBO COMPARATORMatching placebo capsules to GABA
Interventions
food supplement Gama amino butyric acid (GABA) as capsules
Eligibility Criteria
You may not qualify if:
- Type 2 diabetes
- Fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives
- Pregnant or nursing women
- Cancer unless in complete remission for \> 5 years
- Treatment with oral glucocorticoids
- Hypoglycaemia unawareness (unability to register low blood glucose)
- Known or suspected hypersensitivity to trial product or related products
- Abuse of alcohol or drugs, or any other co-existing condition that would make patients unsuitable to participate in the study, as deemed by the investigators
- Receipt of an investigational drug within 30 days prior to visit 0
- Simultaneous participation in any other clinical intervention trial
- Chronic systemic use of steroids
- Seizure disorder
- Current use of Baclofen, Valium, Acamprosate, Neurontin, or Lyrica
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Steno Diabetes Center Copenhagen
Gentofte Municipality, 2820, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
peter Rossing, md
Steno Diabetes Center Copenhagen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- randomised controlled with placebo tablets matching active capsules with investigational product
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2018
First Posted
October 26, 2018
Study Start
October 10, 2018
Primary Completion
May 1, 2019
Study Completion
July 1, 2019
Last Updated
October 26, 2018
Record last verified: 2018-10