GABA Treatment in Subjects With Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

— GABA-1  

Official title:

A Randomised, Double-blind, Placebo-controlled, Parallel Group, Single-centre Trial of GABA Treatment in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03721991
• Other study ID #: H17041847
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: October 2018
• Source: Steno Diabetes Center
• Contact: Peter Rossing, MD
• Phone: 004530913383
• Email: peter.rossing[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

our results indicate that alfa-cells can be regenerated and used to regenerate functional beta-like cells in vivo in type 1 diabetes models. Aiming to eventually apply these findings to type 1 diabetic patients, we initiated multiple screens seeking for compounds inducing alfa-to-beta-cell conversion. Using the mouse as a model, we thereby found that GABA (gamma-aminobutyric acid) could promote a cycle of conversion of alfa-cells into functional beta-like cells,GABA being considered as a non-harmful food supplement, one could envision a trial in type 1 diabetic patients. Indeed, a putative cure for type 1 diabetes may include halting the autoimmune insult to the pancreatic beta-cells and restoring insulin secretion by expanding beta-cell mass by beta-cell-regeneration and/or preventing beta-cell apoptosis induced by cytokines. Immunosuppression initiated at the onset of type 1 diabetes has been shown to preserve beta-cell function, but is associated with significant toxicities. Other studies using nicotinamide and parenteral insulin have failed to prevent development of type 1 diabetes.

Objectives Primary objective: To investigate the effect and safety of the dietary supplement GABA provided at a dose of 6 g daily compared to placebo for 12 weeks on change in beta-cell function in patients with C-peptide negative type 1 diabetes as an adjunctive therapy to insulin treatment.

Population A total of 30 patients with C-peptide negative type 1 diabetes, randomised 2:1 GABA: Placebo.

Intervention After randomisation patients are treated with the dietary supplement GABA or matching placebo, titrated to 3 x 2g, or maximum tolerated dose, for 12 weeks. The insulin dose is reduced if needed according to Self-monitored blood glucose (SMBG) and hypoglycaemic episodes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:stimulated c peptide <0.03 mmol/l type 1 diabetes

Exclusion Criteria:

• • 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Dietary Supplement:
• Gama amino butyric acid (GABA)
food supplement Gama amino butyric acid (GABA) as capsules
• placebo
matching placebo

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Copenhagen	Gentofte

Sponsors (2)

Lead Sponsor	Collaborator
Steno Diabetes Center	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin production	c peptide production during meal stimulation	12 weeks
Secondary	c peptide response (change from fasting baseline to meal stimulated concentration in blood)	maximal c peptide change from baseline during meal testing with sustacal,	after 12 weeks
Secondary	c peptide response beta cell	beta cell sensitivity during meal testing, calculated with Homeostatic Model assessment b (HOMAb)	after 12 weeks
Secondary	glucagon response	increase in blood glucagon concentration from fasting to peak during meal testing,	after 12 weeks
Secondary	metabolic parameters	hba1c (mmol/mol) change from baseline	12 weeks
Secondary	metabolic parameters dose of insulin	insulin dose used pr 24 hours	12 weeks
Secondary	metabolic parameters glucose	hypoglycemia,(number of events of severe and mild hypoglycemia self reported)	12 weeks
Secondary	metabolic parameters lipid	lipid (LDL cholesterol ) (mmol/l)	12 weeks
Secondary	metabolic parameters weight	body weight (kg)	12 weeks
Secondary	metabolic parameters waist	waist circumference (cm)	12 weeks
Secondary	metabolic parameters SMBG	SMBG self monitored blood glucose (mmol/l) 7 points profile in diary	12 weeks
Secondary	metabolic parameters quality of life	Quality of life questionnaire	12 weeks