A Phase II-study (Therapeutic Exploratory) of GAD-alum in Newly Diagnosed Type-1 Diabetic Patients, With Focus One the Presence of Viruses at the Time of Diagnosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies
研究概览
简要总结
The purposes of this study are to test whether GAD vaccination can stop the progression of newly diagnosed type 1 diabetes, to describe the related immunological processes (insulitis) in pancreas and small intestines evolving the mechanism of the effect of GAD vaccination and finally try to detect viruses and virus receptors directly in the insulin producing beta cells of the pancreas in patients with newly diagnosed type-1 diabetes mellitus (T1D).
详细描述
The aetiology of type 1 diabetes is unknown. Both genetic and environmental factors seem to be important for the destruction of insulin producing beta cells in the pancreas. Increasing indirect evidences exist that picornaviruses may either directly or indirectly through autoimmune processes destroy beta cells. New sensitive assays have been developed to detect these viruses and to study the immunological processes, especially T-cell function. Microsurgical technology has been refined, now making pancreatic biopsies a safe procedure. This study focuses on advanced in depth studies of immunology and virology in pancreatic tissue and small intestine at an early stage of disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed classical type-1 diabetes
- •Positive GAD antibodies
- •Fasting C-peptide >0.1 mmol/l
- •Insulin dosage >0.1 U/kg Bodyweight/day
排除标准
- •Pregnancy
- •Other chronic diseases than diabetes
- •Any regular medication except oral contraceptives
- •Psychiatric disturbances
研究组 & 干预措施
GAD-alum
GAD-alum administered at 0 and 1 months after inclusion
干预措施: GAD-alum (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies
时间窗: 2 weeks after inclusion
Prevalence of virus infected islets in pancreatic biopsies
时间窗: 2 weeks after inclusion
次要结局
- Residual insulin secretion (C-peptide) measured by Mixed Meal Tolerance Test(36 months after diagnosis)
- Insulin dosage/kilo bodyweight/24 hours(36 months after diagnosis)
- Glycosylated hemoglobin A1 (HbA1c)(36 months after diagnosis)
研究者
Lars Krogvold
Assosciate professor
Oslo University Hospital