Determination of Dosing and Frequency of BCG Administration Necessary to Alter T-Lymphocyte Profiles in Type I Diabetics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- concentration of autoreactive t-cells
研究概览
简要总结
Type 1 diabetes is caused by an autoimmune destruction of the insulin producing cells of the pancreas. The investigators have discovered the specific autoimmune cells responsible for destroying the insulin-producing cells in an animal model of type 1 diabetes, and the means of destroying those cells.
详细描述
The investigators are now aiming to use a similar strategy (vaccination with BCG, the vaccine used world-wide to protect against tuberculosis) in human type 1 diabetes to see if the abnormal immune cells can be depleted. This is the first step in trying to cure established type 1 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(Type 1 diabetic subjects):
- •Type 1 diabetes treated continuously with insulin from time of diagnosis
- •Age 18-55
- •Anti-GAD positive
- •HIV antibody negative
- •Normal CBC
- •Negative intermediate PPD test performed and read by study staff
- •HCG Negative (females)
排除标准
- •Type 1 diabetic subjects):
- •History of chronic infectious disease, such as HIV
- •History of tuberculosis, TB risk factors, or history of + PPD, or BCG vaccination
- •Treatment with glucocorticoids (other than intermittent nasal steroids) or disease or condition likely to require steroid therapy
- •Other conditions or treatments associated with increased risk of infections such as patients with previous history of severe burns, or treatment with immunosuppressive medications of any type (e.g. imuran, methotrexate, cyclosporine, etanercept, infliximab) for any reason
- •Current treatment with aspirin > 160 mg/day or chronic, daily NSAIDs
- •Fasting or stimulated (1 mg glucagon stimulation test) c-peptide > 0.2 pmol/mL
- •History of keloid formation
- •HbA1c > 8.0%
- •History or evidence of chronic kidney disease (serum creatinine > 1.5 mg/dL)
- •History of proliferative diabetic retinopathy that has not been treated with laser therapy
- •Pregnant or not using acceptable birth control
- •Living with someone who is immunosuppressed and/or at high risk for infectious diseases (for example HIV+ or taking immunosuppressive medications for any reason).
- •Inclusion Criteria (Control Non-diabetic Subjects):
- •Age 18-45
- •Exclusion Criteria (Control Non-diabetic Subjects):
- •History of autoimmune diseases or diabetes
- •History of HIV History of autoimmune disease or type 1 diabetes (use of insulin continuously since diagnosis) in first degree family members
研究组 & 干预措施
P
Saline vaccination
干预措施: Saline (Biological)
E
BCG vaccination
干预措施: BCG (Biological)
结局指标
主要结局
concentration of autoreactive t-cells
时间窗: Measured weekly in first 8 weeks, then every other week for weeks 8-12
次要结局
- Concentration of TNF, TNF-receptors, other cytokines, and c-peptide levels(Weekly for first 8 weeks, then every other week for weeks 8-12)
研究者
David M. Nathan, MD
Director, Diabetes Center
Massachusetts General Hospital