Clinical trial NCT04330196: Effect of Postprandial Hyperinsulinaemic Hypoglycaemia on Driving Performance.
Official title: Deciphering the Enigma of Postprandial Hyperinsulinaemic Hypoglycaemia After Bariatric Surgery, Part 1 C: Effect of Postprandial Hypoglycaemia on Driving Performance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Roux-en-Y Gastric Bypass
Postprandial Hypoglycemia
Driving Impaired
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will undergo two experiments in random order. In the experiments, driving performance will be assessed after administration of glucose (intervention arm) or aspartame (control arm).
Primary purpose: BASIC_SCIENCE

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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Estimated difference in driving performance across driving features over the glycemic trajectory after glucose vs. aspartame intake
timeFrame: From -15 to 150 minutes after glucose/aspartame intake
Secondary outcomes:
measure: Hypoglycemic symptoms over the glycemic trajectory after glucose vs. aspartame intake
timeFrame: From -15 to 180 minutes after glucose/aspartame intake
measure: Cognitive test performance after glucose vs. aspartame intake
timeFrame: 135 minutes after glucose/aspartame intake
Other outcomes:
measure: Time course of the hormonal response after glucose/aspartame intake
timeFrame: From -15 to 120 minutes after glucose/aspartame intake
measure: Heart rate after glucose/aspartame intake
timeFrame: From -15 to 180 minutes after glucose/aspartame intake
Locations:
city: Bern
country: Switzerland
facility: Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
Study officials:
affiliation: University Hopsital Bern, University of Bern
name: Lia Bally, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: