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GABA Treatment in Subjects With Type 1 Diabetes (GABA-1)

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ClinicalTrials.gov Identifier: NCT03721991
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : October 26, 2018
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Steno Diabetes Center

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

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Dietary Supplement: Gama amino butyric acid (GABA) Dietary Supplement: placebo Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomised controlled study with active compared to placebo for 12 weeks
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: randomised controlled with placebo tablets matching active capsules with investigational product
Primary Purpose: Basic Science
Official Title: A Randomised, Double-blind, Placebo-controlled, Parallel Group, Single-centre Trial of GABA Treatment in Subjects With Type 1 Diabetes
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Active Comparator: GABA
gamma Amino butyric acid (GABA) food supplement with 6 g per day
Dietary Supplement: Gama amino butyric acid (GABA)
food supplement Gama amino butyric acid (GABA) as capsules
Other Name: gaba

Placebo Comparator: PLACEBO
Matching placebo capsules to GABA
Dietary Supplement: placebo
matching placebo




Primary Outcome Measures :
  1. insulin production [ Time Frame: 12 weeks ]
    c peptide production during meal stimulation


Secondary Outcome Measures :
  1. c peptide response (change from fasting baseline to meal stimulated concentration in blood) [ Time Frame: after 12 weeks ]
    maximal c peptide change from baseline during meal testing with sustacal,

  2. c peptide response beta cell [ Time Frame: after 12 weeks ]
    beta cell sensitivity during meal testing, calculated with Homeostatic Model assessment b (HOMAb)

  3. glucagon response [ Time Frame: after 12 weeks ]
    increase in blood glucagon concentration from fasting to peak during meal testing,

  4. metabolic parameters [ Time Frame: 12 weeks ]
    hba1c (mmol/mol) change from baseline

  5. metabolic parameters dose of insulin [ Time Frame: 12 weeks ]
    insulin dose used pr 24 hours

  6. metabolic parameters glucose [ Time Frame: 12 weeks ]
    hypoglycemia,(number of events of severe and mild hypoglycemia self reported)

  7. metabolic parameters lipid [ Time Frame: 12 weeks ]
    lipid (LDL cholesterol ) (mmol/l)

  8. metabolic parameters weight [ Time Frame: 12 weeks ]
    body weight (kg)

  9. metabolic parameters waist [ Time Frame: 12 weeks ]
    waist circumference (cm)

  10. metabolic parameters SMBG [ Time Frame: 12 weeks ]
    SMBG self monitored blood glucose (mmol/l) 7 points profile in diary

  11. metabolic parameters quality of life [ Time Frame: 12 weeks ]
    Quality of life questionnaire



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721991


Contacts
Contact: Peter Rossing, MD 004530913383 peter.rossing@regionh.dk

Locations
Denmark
Steno Diabetes Center Copenhagen Recruiting
Gentofte, Denmark, 2820
Contact: Peter Rossing, MD       peter.rossing@regionh.dk   
Principal Investigator: Peter Rossing, MD         
Sponsors and Collaborators
Steno Diabetes Center
Juvenile Diabetes Research Foundation
Investigators
Study Chair: peter Rossing, md Steno Diabetes Center Copenhagen

Responsible Party: Steno Diabetes Center
ClinicalTrials.gov Identifier: NCT03721991     History of Changes
Other Study ID Numbers: H17041847
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: data protection rules may not approve data sharing

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Steno Diabetes Center:
beta cell

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
gamma-Aminobutyric Acid
Butyric Acid
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine Antagonists
Histamine Agents