Tissue Distribution of F18-FDG Labeled Autologous Bone Marrow Derived Stem Cells in Patients With Type2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 主要终点
- Increase in glucagon stimulated C peptide level
研究概览
简要总结
Stem cells have promising potential in treating diabetes. However the therapeutic outcome in diabetic patients will profoundly depend on their delivery to pancreas. Our objective is to label stem cells with PET tracer F18-FDG to carry out in vivo cell tracking. The labeled stem cells will be given through different routes (intravenous and intraarterial)and tissue distribution studied. Patients will be followed up for the next 6 months. Glucagon stimulated C peptide will be measured at baseline and at 6 months and HOMA IR and HOMA beta will be calculated.
详细描述
Our objective is to label stem cells with PET tracer F18-FDG to carry out in vivo cell tracking. The labeled stem cells will be given through different routes (intravenous and intraarterial)and tissue distribution studied. Patients will be followed up for the next 6 months. Glucagon stimulated C peptide will be measured at baseline and at 6 months and HOMA IR and HOMA beta will be calculated.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients with type 2 diabetes mellitus between 30 and 65 years of age.
- •Duration of diabetes ≥ 5 years.
- •Failure to triple OHA in optimal doses {glimepiride (4 gm), metformin(2-2.5 gm) and pioglitazone(15mg)}.
- •Requiring insulin therapy for last six month
- •On stable doses of insulin (≥0.4 IU/kg/day, Vildagliptin, metformin (2 gm), pioglitazone (15mg) for last three months.
- •GAD antibody negative status.
排除标准
- •Patients with type 1 diabetes mellitus or secondary diabetes
- •Patients with serum creatinine > 1.5 mg/dL
- •Abnormal liver function tests (defined as value of transaminases > 3 times the upper value of normal or serum bilirubin higher than normal for the reference value for the laboratory).
- •History of cholecystitis/ cholelithiasis/ cholecystectomy.
- •Seropositivity for HIV, HBsAg and HCV.
- •History of myocardial infarction or unstable angina or any cardiovascular events in the previous 3 months.
结局指标
主要结局
Increase in glucagon stimulated C peptide level
时间窗: 6 months
次要结局
未报告次要终点
研究者
Anil Bhansali
Head, Dept of Endocrinology
Post Graduate Institute of Medical Education and Research, Chandigarh