Effect of Postprandial Hyperinsulinaemic Hypoglycaemia on Driving

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04330196
Study type	Interventional
Source	University Hospital Inselspital, Berne
Contact
Status	Completed
Phase	N/A
Start date	July 8, 2020
Completion date	December 3, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Postprandial Hyperinsulinaemic Hypoglycaemia on Driving Performance. — DEEP1C

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms