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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucose condition | Experimental | In the experimental condition patients ingest 200ml of water containing 75g of glucose |
|
| Control condition | Placebo Comparator | In the control condition patients ingest 200ml of water sweetened with 700mg of aspartame |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral glucose tolerance test | Diagnostic Test | Participant ingests 75g of glucose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cognitive test performance after glucose vs. aspartame intake |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Heart rate after glucose/aspartame intake |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lia Bally, MD, PhD | University Hopsital Bern, University of Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital | Bern | 3010 | Switzerland |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005951 | Glucose Tolerance Test |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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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).
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Participants will be masked to the type of beverage ingested at each visit (200ml of water containing glucose or aspartame). Furthermore, participants will be masked to glucose levels throughout the study
| Ingestion of placebo |
| Diagnostic Test |
Participant ingests 700mg of aspartame |
|
Cognitive function will be assessed using the Digit Symbol Substitution Test |
| 135 minutes 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 |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008919 | Investigative Techniques |