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Search / Trial NCT04330196

Effect of Postprandial Hyperinsulinaemic Hypoglycaemia on Driving Performance.

Launched by LIA BALLY · Mar 30, 2020

Trial Information

Current as of May 27, 2025

Completed

Keywords

ClinConnect Summary

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 hypoglycaem...

Gender

ALL

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

About Lia Bally

Lia Bally is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative therapeutic solutions. With a focus on rigorous scientific methodology and ethical standards, Lia Bally collaborates with leading healthcare professionals and institutions to design and conduct clinical trials across various therapeutic areas. Their mission is to facilitate the development of safe and effective treatments, while prioritizing participant safety and well-being. By fostering transparency and collaboration, Lia Bally aims to contribute significantly to the global healthcare landscape and enhance the quality of life for patients worldwide.

Locations

Bern, , Switzerland

Patients applied

0 patients applied

Trial Officials

Lia Bally, MD, PhD

Principal Investigator

University Hopsital Bern, University of Bern

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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