NCT05597475Unknown不适用
Visualizing Beta Cells in Patients With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
Rijnstate Hospital1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pancreatic uptake of 68Ga-NODAGA-exendin-4
研究概览
简要总结
In order to evaluate the difference in beta cell mass in patients with and without hyperinsulinemic hypoglycemia after Roux en Y gastric bypass (RYGB) investigators aim to compare quantitative PET imaging of the pancreas between these patient groups.
These highly relevant data will provide investigators with more information on the possible role of beta cell mass in the mechanisms of hyperinsulinemic hypoglycemia bariatric surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •- Persisting hyperinsulinemic hypoglycemia after a low-carbohydrate diet and/or insulin suppressive medication for one year.
- •RYGB at least 2 years ago
- •Normal glucose levels before and after RYGB (fasting glucose between 4 and 6 mmol/l or HbA1c between 20 and 42 mmol/mol)
- •Score ≤ 7 on Sigstad's scoring system (Table 1)
- •Hypoglycemia excluded by 14-day continuous glucose monitoring
- •Individual matched to HH group on age (± 5 years), sex and BMI at time of inclusion (± 2 kg/m2)
排除标准
- •Anti-diabetic medication in the past 6 months
- •Treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors in the past six months.
- •Known liver failure or serum liver values over 2 times normal value at the time of standard laboratory assessment. Normal values of total bilirubin, γ-GT, ASAT and albumin are <21 μmol, <40 U/l, <30 U/l and 35-50 g/l respectively
- •Pregnancy or the wish to become pregnant within 6 months
- •Breast feeding
- •Kidney failure, i.e. calculated creatinine clearance below 40 ml/min
- •Age < 18 years
- •No signed informed consent
结局指标
主要结局
Pancreatic uptake of 68Ga-NODAGA-exendin-4
时间窗: baseline
次要结局
- Beta cell function(baseline)
研究者
Laura Deden
Principal Investigator
Rijnstate Hospital
研究点 (1)
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