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 | |
---|---|---|---|
Active, not recruiting |
NCT04422236 -
A Post-market, Observational Registry With the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Bariatric Surgery
|
||
Withdrawn |
NCT04543526 -
A Post-market Observational Study With the easyEndoTM Universal Linear Cutting Stapler in Standard Laparoscopic and Robot-assisted Laparoscopic Roux-en-Y Gastric Bypass (RYGB) Surgery
|
||
Completed |
NCT01867255 -
Study to Examine the Effect of Gastric Bypass Surgery on Venlafaxine ER Blood Levels
|
Phase 1 | |
Completed |
NCT04334161 -
Evaluation of the Neuro-endocrine Response to Post-prandial Hyperinsulinaemic Hypoglycaemia.
|
||
Completed |
NCT03440138 -
Defining Benchmarks in Bariatric Surgery
|
||
Completed |
NCT04972357 -
Bariatric Procedures and Changes Gastric Passage
|
||
Active, not recruiting |
NCT03049696 -
Does Participation in a Pre-Operative Physical Activity Program Improve Patient Outcomes and Quality of Life?
|
N/A | |
Not yet recruiting |
NCT06350955 -
IV Iron-induced Hypophosphatemia After RYGB
|
Phase 4 | |
Completed |
NCT02128581 -
A Dose-response of the Effects of Exendin-9,39 on GI Symptoms and Food Intake
|
Phase 1 | |
Completed |
NCT03478098 -
Meal Glycaemic Index and Exercise After Gastric Bypass
|
N/A | |
Recruiting |
NCT04808206 -
A Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy
|
||
Completed |
NCT04600596 -
Photographic Food Recognition and Meal Size Estimation Before and After Roux-en-Y Gastric Bypass
|
||
Completed |
NCT03968757 -
Assessing the Safety and Performance of the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Gastric Bypass Surgery
|
||
Active, not recruiting |
NCT02068001 -
Changes in Food Preference and Food Cue Responsivity After Bariatric Surgery
|
N/A | |
Completed |
NCT02204813 -
To Define the Role of GLP-1 for Improving Glucose Homeostasis in Humans Following Gastric Bypass Surgery
|
Phase 1 | |
Recruiting |
NCT04324515 -
Randomized Trial Comparing Gastric Bypass With and Without Cholecystectomy
|
N/A | |
Completed |
NCT05560789 -
The Effect of Physical Activity in Individuals With Post-bariatric Hypoglycemia
|
N/A | |
Not yet recruiting |
NCT04172116 -
Continuous Glucose Monitoring (CGM) After Surgical Variations of the Roux-en-y Gastric Bypass
|
||
Completed |
NCT04609449 -
A Comparison Between Short vs. Long Biliopancreatic Limb Gastric Bypass
|
N/A | |
Completed |
NCT05212207 -
Forecasting and Preventing Post-Bariatric Hypoglycaemia WP 1
|