Status:
COMPLETED
Effect of Postprandial Hyperinsulinaemic Hypoglycaemia on Driving Performance.
Lead Sponsor:
Lia Bally
Conditions:
Roux-en-Y Gastric Bypass
Postprandial Hypoglycemia
Eligibility:
All Genders
18+ years
Phase:
NA
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 confi...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04330196
Start Date
July 8 2020
End Date
December 3 2020
Last Update
February 18 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
Bern, Switzerland, 3010