Roux-en-Y Gastric Bypass Clinical Trial
— DEEP1COfficial title:
Deciphering the Enigma of Postprandial Hyperinsulinaemic Hypoglycaemia After Bariatric Surgery, Part 1 C: Effect of Postprandial Hypoglycaemia on Driving Performance.
NCT number | NCT04330196 |
Other study ID # | DEEP1C |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 8, 2020 |
Est. completion date | December 3, 2020 |
Verified date | February 2021 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital | Bern |
Lead Sponsor | Collaborator |
---|---|
Lia Bally |
Switzerland,
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 |
Status | Clinical Trial | Phase | |
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