A Randomised, Double-blind, Placebo-controlled, Parallel Group, Single-centre Trial of GABA Treatment in Subjects With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- insulin production
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
randomised controlled with placebo tablets matching active capsules with investigational product
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stimulated c peptide <0.03 mmol/l type 1 diabetes
排除标准
- •• 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
结局指标
主要结局
insulin production
时间窗: 12 weeks
c peptide production during meal stimulation
次要结局
- metabolic parameters dose of insulin(12 weeks)
- metabolic parameters SMBG(12 weeks)
- metabolic parameters quality of life(12 weeks)
- c peptide response beta cell(after 12 weeks)
- c peptide response (change from fasting baseline to meal stimulated concentration in blood)(after 12 weeks)
- metabolic parameters(12 weeks)
- glucagon response(after 12 weeks)
- metabolic parameters glucose(12 weeks)
- metabolic parameters lipid(12 weeks)
- metabolic parameters weight(12 weeks)
- metabolic parameters waist(12 weeks)