Effect of Postprandial Hyperinsulinaemic Hypoglycaemia on Driving Performance.

Roux-en-Y Gastric Bypass Clinical Trial

— DEEP1C  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04330196
• Other study ID #: DEEP1C
• Status: Completed
• Phase: N/A
• Start date: July 8, 2020
• Est. completion date: December 3, 2020

Study information

• Verified date: February 2021
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 3, 2020
• Est. primary completion date: December 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Hyperinsulinism
• Driving Impaired
• Hypoglycemia
• Postprandial Hypoglycemia
• Roux-en-Y Gastric Bypass

Intervention

Diagnostic Test:
• Oral glucose tolerance test
Participant ingests 75g of glucose
• Ingestion of placebo
Participant ingests 700mg of aspartame

Locations

Country	Name	City	State
Switzerland	Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Lia Bally

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time course of the hormonal response after glucose/aspartame intake	Insulin, C-peptide, Adrenalin, Noradrenalin, Glucagon, Cortisol, Growth hormone, PYY will be measured in pre-defined timepoints	From -15 to 120 minutes after glucose/aspartame intake
Other	Heart rate after glucose/aspartame intake	An ECG will be used to measure heart rate after glucose and aspartame intake	From -15 to 180 minutes after glucose/aspartame intake
Primary	Estimated difference in driving performance across driving features over the glycemic trajectory after glucose vs. 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	From -15 to 150 minutes after glucose/aspartame intake
Secondary	Hypoglycemic symptoms over the glycemic trajectory after glucose vs. 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)	From -15 to 180 minutes after glucose/aspartame intake
Secondary	Cognitive test performance after glucose vs. aspartame intake	Cognitive function will be assessed using the Digit Symbol Substitution Test	135 minutes after glucose/aspartame intake