EUCTR2014-005599-27-NL进行中（未招募）1 期
Visualizing beta cells in morbid obese patients with T2D before and after bariatric surgery(NL51980.091.15) - Visualizing beta cells before and after bariatric surgery
Radboud University Medical Center Nijmegen0 个研究点目标入组 12 人开始时间: 2016年9月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- Morbid obese T2D patient who will undergone RYGB at the Rijnstate in Arnhem (BMI > 35 kg/m2)
- •- Signed informed consent
- •Mild T2D group
- •o C-peptide > 1.3 nmol/l
- •o T2D diagnosis < 2 years before RYGB
- •o Only metformin usage as anti-diabetic medication
- •Severe T2D group
- •o C-peptide < 1 nmol/l
- •o T2D diagnosis > 4 years before RYGB
- •o Insulin and/or sulfonylurea (SU) usage
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Fasting glucose < 7 mmol/l at time C-peptide was determined (Aarts et al. 2013)
- •- Known liver failure or serum liver values over 2 times normal value at the time of standard laboratory assessment.
- •- BMI > 50 kg/m2
- •- Previous treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors
- •- Pregnancy or the wish to become pregnant within 18 months
- •- Breast feeding
- •- Kidney failure, i.e. calculated creatinine clearance below 40ml/min
- •- Age < 18 years
- •- No signed informed consent
研究者
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