Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- time to symptomatic hypoglycemia after exenatide test compared to placebo
研究概览
简要总结
This study is to evaluate the concept of the exenatide test for diagnosis of EHH (earlier induction of symptomatic hypoglycemia compared to placebo within 4 hours after injection).
详细描述
Endogenous hyperinsulinemic hypoglycemia (EHH) is defined as inappropriate endogenous insulin secretion leading to hypoglycemia and associated symptoms. The most frequent diagnosis is an insulin-secreting pancreatic neuroendocrine tumor, but other diagnoses such as nesidioblastosis of the pancreatic islets are also possible. Biochemically, EHH is characterized by low glucose concentrations in the presence of inappropriately increased C-peptide (endogenous insulin secretion) and insulin levels. The conventional fasting test is at present the gold standard to document EHH.
Radiolabeled Exenatide for localizing insulinomas in patients with biochemically proven EHH has been evaluated and an exenatide-test in an outpatient setting may be able to replace the fasting test, by an early symptomatic hypoglycemia compared to a prolonged inpatient monitoring.
This study is to investigate the concept of the exenatide test to diagnose EHH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by signature
- •Biochemically proven endogenous hyperinsulinemic hypoglycemia: neuroglycopenic symptoms in the fasting state with low plasma glucose, inappropriately high serum insulin and C-peptide concentrations (standardized 72h fasting test).).
- •Participants as control subjects fulfilling all of the following inclusion criteria are eligible for the study:
- •Inclusion Criteria:
- •Informed Consent as documented by signature (Appendix Informed Consent Form)
- •Possession of the adequate match criteria (age, BMI and gender) to patients with suspicion for an insulinoma
排除标准
- •Known hypersensitivity or allergy to Exenatide
- •Pregnant or breastfeeding female patients. A pregnancy test will be performed in all women of child bearing potential.
- •Calculated creatinine clearance below 40 ml/min
- •No signed informed consent
- •Intake of any glucagon-like peptide (GLP)-1 analogue (such as Byetta® or Bydureon®[= Exenatide])
- •prediabetes or diabetes (HbA1c > 5.7 %)
- •Previous abdominal surgery in the gastrointestinal tract
- •Any concomitant glucose-lowering drug (i. e. insulin, sulfonyl urea)
- •Any known intolerance to standardized meal (Maizena)
- •Any uncontrolled significant medical, psychiatric or surgical condition (active infection, unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension, uncontrolled congestive heart disease, etc.) or laboratory findings that might jeopardize the patient's safety or that would limit compliance with the objectives and assessments of the study.
- •Any mental conditions which prevent the patient from understanding the type, extent and possible consequences of the study and/or an uncooperative attitude from the patient
研究组 & 干预措施
Group A (EHH Patients)
Group A will receive a placebo injection (0.9% saline solution) on Day 1 and 10μg Exenatide injection on Day 2.
干预措施: Exenatide (Drug)
Group A (EHH Patients)
Group A will receive a placebo injection (0.9% saline solution) on Day 1 and 10μg Exenatide injection on Day 2.
干预措施: 0.9% saline solution (Drug)
Group B (EHH Patients)
Group B will receive a 10μg Exenatide injection on Day 1 and placebo injection (0.9% saline solution) on Day 2.
干预措施: Exenatide (Drug)
Group B (EHH Patients)
Group B will receive a 10μg Exenatide injection on Day 1 and placebo injection (0.9% saline solution) on Day 2.
干预措施: 0.9% saline solution (Drug)
Group C (control subjects)
Control subjects without evidence for EHH defined by no glucose levels below 3.0 mmol/l during a 7-day CGFS (Freestyle libre) and matched to EHH patients for age, gender and BMI will receive only on one study day a single intravenous injection of 10μg Exenatide and compared to group A patients on Day 2. They will not receive a Placebo injection.
干预措施: Exenatide (Drug)
结局指标
主要结局
time to symptomatic hypoglycemia after exenatide test compared to placebo
时间窗: within 4 hours after injection
time to symptomatic hypoglycemia after exenatide test compared to placebo
次要结局
- time to symptoms(within 4 hours after injection)
- time dependent decrease (time Δ from injection in min) of blood glucose (% or mmol/l))(within 4 hours after injection)
- time to hypoglycemia (time to reach blood sugar level ≤ 2.5 mmol/l) in the exenatide test in comparison to the placebo(within 4 hours after injection)
- change in levels of plasma glucose compared to placebo compared to placebo(within 4 hours after injection)
- time to symptoms in the exenatide test in comparison to the fasting test(within 4 hours after injection)
- change in levels of proinsulin compared to placebo(within 4 hours after injection)
- change in levels of ß-hydroxybutyrate compared to placebo(within 4 hours after injection)
- costs of exenatide test setting (CHF)(within 4 hours after injection)
- time to hypoglycemia (time to reach blood sugar level ≤ 2.5 mmol/l) in the exenatide test in comparison to the fasting test(within 4 hours after injection)
- change in levels of insulin compared to placebo(within 4 hours after injection)
- change in levels of C-peptide compared to placebo(within 4 hours after injection)