Type 1 Diabetes Clinical Trial
Official title:
Effects Of Gamma Aminobutyric Acid On The Progression Of New Onset Juvenile
This study is a multicenter, randomized, double-masked, placebo-controlled clinical study.
All groups will receive standard intensive diabetes treatment with insulin and life style
management. 60 subjects will be randomly assigned in a 1:1:1 ratio to receive placebo or
different dosage of GABA.
GABA is an amino acid produced from glutamate by glutamic acid decarboxylase. It was
approved for the treatment of hepatic coma, fibromyalgia, ataxia in China and is widely used
as supplement for the treatment of epilepsy, insomnia, stress and tobacco dependence. It has
been recently shown that GABA can prevent and reverse the development of diabetes in type 1
mice models. Participants will receive placebo or GABA for 52 weeks.
The study will consist of 4 weeks screening period, 2 weeks run-in period, 52 weeks
treatment period and 4 weeks follow-up period. Enrollment is expected to occur over 2 years.
To assess the efficacy and safety of GABA for the treatment of juvenile type 1 diabetes in
new onset subjects.
Primary Outcome:
The primary statistical hypothesis to be assessed in this study is whether the mean
C-peptide value for study subjects receiving GABA differs significantly from the mean value
for placebo subjects assessed at follow-up.
Secondary Outcome:
The study will examine the HbA1C and the daily dosage of insulin (units/kg).
Exploratory Endpoint:
The study will assess the effects of treatment on inflammatory markers and immunological
outcomes.
Major Inclusion Criteria:
Type 1 diabetes within past 6 months Age 5-21 years* At least one diabetes associated
autoantibody
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05653518 -
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
|
N/A | |
| Enrolling by invitation |
NCT05515939 -
Evaluating the InPen in Pediatric Type 1 Diabetes
|
||
| Completed |
NCT05109520 -
Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
|
||
| Recruiting |
NCT04016987 -
Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes
|
N/A | |
| Active, not recruiting |
NCT04190368 -
Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes
|
N/A | |
| Recruiting |
NCT05413005 -
Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus
|
Early Phase 1 | |
| Active, not recruiting |
NCT04668612 -
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
|
N/A | |
| Completed |
NCT02837094 -
Enhanced Epidermal Antigen Specific Immunotherapy Trial -1
|
Phase 1 | |
| Recruiting |
NCT05414409 -
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
|
Phase 2 | |
| Recruiting |
NCT05670366 -
The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes
|
N/A | |
| Active, not recruiting |
NCT05418699 -
Real-life Data From Diabetic Patients on Closed-loop Pumps
|
||
| Completed |
NCT04084171 -
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
|
N/A | |
| Recruiting |
NCT06144554 -
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
|
||
| Recruiting |
NCT05153070 -
Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
|
Phase 2 | |
| Recruiting |
NCT05379686 -
Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
|
N/A | |
| Completed |
NCT05281614 -
Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D
|
Early Phase 1 | |
| Withdrawn |
NCT04259775 -
Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
|
N/A | |
| Active, not recruiting |
NCT01600924 -
Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
|
||
| Completed |
NCT02914886 -
Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS)
|
Phase 4 | |
| Completed |
NCT02855307 -
Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes
|
Phase 2 |