跳至主要内容
临床试验/NCT04330196
NCT04330196已完成不适用

Deciphering the Enigma of Postprandial Hyperinsulinaemic Hypoglycaemia After Bariatric Surgery, Part 1 C: Effect of Postprandial Hypoglycaemia on Driving Performance.

Lia Bally2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年7月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
2
主要终点
Estimated difference in driving performance across driving features over the glycemic trajectory after glucose vs. aspartame intake

研究概览

简要总结

The primary objective of this study is to assess the effect of the natural course of postprandial hypoglycemia vs. a postprandial euglycaemic condition on driving performance in individuals with confirmed postprandial hyperinsulinaemic hypoglycaemia after gastric-bypass surgery.

详细描述

Despite the increasing prevalence of postprandial hyperinsulinaemic hypoglycaemia (PHH), clinical implications are still unclear. Anecdotal evidence from patients with PHH suggest a high burden for these patients due to the recurrent hypoglycaemias with possibly debilitating consequences. It is well established, that even mild hypoglycaemia (plasma glucose of 3.4mmol/l) in diabetic and non-diabetic significantly impairs cognitive-motor functioning. Of note, some of the cognitive aspects remain impaired for up to 75min, even when the hypoglycaemia is corrected. In addition to the hypoglycaemic blood glucose levels per se, the dynamics of the hypoglycaemia occurrence appears to play a role. It was shown in individuals with type 1 diabetes, that cognitive functions are affected more during a fast-fall than slow fall hypoglycaemia in the postprandial state.

Driving is a frequent daily activity which integrates various mental function including visual and auditory processing, motor skills, reasoning and problem solving. Due to the potentially dangerous consequences, avoidance of hypoglycaemia-induced driving mishaps is of uttermost importance. Several studies have evaluated the impact of induced, controlled hypoglycaemia in individuals with type 1 diabetes on driving performance using driving simulators but data in PHH patients are currently lacking. Assessing the potential impact of the natural course of postprandial hypoglycaemia on driving performance in PHH patients will contribute to a better understanding of the consequences and relevance of this problem. The investigator will test the hypothesis whether driving performance during the postprandial glucose dynamics is impaired in patients with confirmed PHH.

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
Single (Participant)

盲法说明

Participants will be masked to the type of beverage ingested at each visit (200ml of water containing glucose or aspartame). Furthermore, participants will be masked to glucose levels throughout the study

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged ≥18 years
  • Roux-en-Y gastric bypass ≥1 year ago
  • PHH defined as postprandial plasma or sensor glucose<3.0mmol/l according to the International Hypoglycaemia Study Group (1) and exclusion of other causes of hypoglycaemia
  • Possession of a valid Swiss driver's license. Passed driver's examination at least 3 years before study inclusion. Active driving in the last 6 months before the study.

排除标准

  • Clinically relevant weight changes (≥5%) within the past 3 months
  • Incapacity to give informant consent
  • Historical or current diabetes based on HbA1c ≥6.5% without glucose-lowering treatment
  • Haemoglobin level below 11 g/dl
  • Ongoing treatment with glucose-lowering drugs, anorectic drugs, steroids or any medications known to affect gastric motility
  • Active heart, lung, liver, gastrointestinal, renal or neurological disease
  • Inability to follow study procedures
  • Pregnancy or breast-feeding

结局指标

主要结局

Estimated difference in driving performance across driving features over the glycemic trajectory after glucose vs. aspartame intake

时间窗: From -15 to 150 minutes after glucose/aspartame intake

The pooled effect (z-score difference), which is the compound change in driving performance across driving features between the glucose and aspartame condition, will be calculated using a Bayesian hierarchical regression model

次要结局

  • Hypoglycemic symptoms over the glycemic trajectory after glucose vs. aspartame intake(From -15 to 180 minutes after glucose/aspartame intake)
  • Cognitive test performance after glucose vs. aspartame intake(135 minutes after glucose/aspartame intake)

研究者

发起方
Lia Bally
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lia Bally

Professor

Insel Gruppe AG, University Hospital Bern

研究点 (2)

Loading locations...

相似试验