Ignite Creation Date:
2024-05-06 @ 2:30 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04330196
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2020-03-30
Brief Title:
Effect of Postprandial Hyperinsulinaemic Hypoglycaemia on Driving Performance
Sponsor:
Lia Bally
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Deciphering the Enigma of Postprandial Hyperinsulinaemic Hypoglycaemia After Bariatric Surgery Part 1 C Effect of Postprandial Hypoglycaemia on Driving Performance
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEEP1C
Brief 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
Detailed 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 34mmoll 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None