Skip to main content
OpenTrials
Completed

NCT Number: NCT04330196

Effect of Postprandial Hyperinsulinaemic Hypoglycaemia on Driving Performance.

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral glucose tolerance test

Diagnostic Test

Participant ingests 75g of glucose

Ingestion of placebo

Diagnostic Test

Participant ingests 700mg of aspartame

Primary outcomes

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

    Time frame: 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

Secondary outcomes

  1. Hypoglycemic symptoms over the glycemic trajectory after glucose vs. aspartame intake

    Time frame: From -15 to 180 minutes after glucose/aspartame intake

    Hypoglycemic symptoms will be rated using the Edinburgh Hypoglycemia Symptom Scale (minimum score=11, maximum score=77, a higher score, means more symptoms)

  2. Cognitive test performance after glucose vs. aspartame intake

    Time frame: 135 minutes after glucose/aspartame intake

    Cognitive function will be assessed using the Digit Symbol Substitution Test

Other outcomes

  1. Time course of the hormonal response after glucose/aspartame intake

    Time frame: From -15 to 120 minutes after glucose/aspartame intake

    Insulin, C-peptide, Adrenalin, Noradrenalin, Glucagon, Cortisol, Growth hormone, PYY will be measured in pre-defined timepoints

  2. Heart rate after glucose/aspartame intake

    Time frame: From -15 to 180 minutes after glucose/aspartame intake

    An ECG will be used to measure heart rate after glucose and aspartame intake

Sponsors and collaborators

Lead sponsor

Lia Bally

Other

Registry information

Official study title

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

Acronym: DEEP1C

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 1, 2020
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.