DEEP1C: Effect of Postprandial Hyperinsulinaemic Hypoglycaemia on Driving Performance.

Sponsor

Lia Bally (Other)

Overall Status

Completed

CT.gov ID

NCT04330196

Collaborator

(none)

Enrollment

Location

Arms

4.9

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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 confirmed postprandial hyperinsulinaemic hypoglycaemia after gastric-bypass surgery.

Condition or Disease	Intervention/Treatment	Phase
Roux-en-Y Gastric Bypass Postprandial Hypoglycemia Driving Impaired	Diagnostic Test: Oral glucose tolerance test Diagnostic Test: Ingestion of placebo	N/A

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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).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).

Masking:

Single (Participant)

Masking Description:

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

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jul 8, 2020

Actual Primary Completion Date :

Dec 3, 2020

Actual Study Completion Date :

Dec 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Glucose condition In the experimental condition patients ingest 200ml of water containing 75g of glucose	Diagnostic Test: Oral glucose tolerance test Participant ingests 75g of glucose
Placebo Comparator: Control condition In the control condition patients ingest 200ml of water sweetened with 700mg of aspartame	Diagnostic Test: Ingestion of placebo Participant ingests 700mg of aspartame

Arm

Intervention/Treatment

Experimental: Glucose condition

In the experimental condition patients ingest 200ml of water containing 75g of glucose

Diagnostic Test: Oral glucose tolerance test

Participant ingests 75g of glucose

Placebo Comparator: Control condition

In the control condition patients ingest 200ml of water sweetened with 700mg of aspartame

Diagnostic Test: Ingestion of placebo

Participant ingests 700mg of aspartame

Outcome Measures

Primary Outcome Measures

Estimated difference in driving performance across driving features over the glycemic trajectory after glucose vs. aspartame intake [From -15 to 150 minutes after glucose/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

Secondary Outcome Measures

Hypoglycemic symptoms over the glycemic trajectory after glucose vs. aspartame intake [From -15 to 180 minutes after glucose/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)
Cognitive test performance after glucose vs. aspartame intake [135 minutes after glucose/aspartame intake]
Cognitive function will be assessed using the Digit Symbol Substitution Test

Other Outcome Measures

Time course of the hormonal response after glucose/aspartame intake [From -15 to 120 minutes after glucose/aspartame intake]
Insulin, C-peptide, Adrenalin, Noradrenalin, Glucagon, Cortisol, Growth hormone, PYY will be measured in pre-defined timepoints
Heart rate after glucose/aspartame intake [From -15 to 180 minutes after glucose/aspartame intake]
An ECG will be used to measure heart rate after glucose and aspartame intake

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital	Bern		Switzerland	3010

Sponsors and Collaborators

Lia Bally

Investigators

Principal Investigator: Lia Bally, MD, PhD, University Hopsital Bern, University of Bern

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lia Bally, Professor, University Hospital Inselspital, Berne

ClinicalTrials.gov Identifier:

NCT04330196

Other Study ID Numbers:

DEEP1C

First Posted:

Apr 1, 2020

Last Update Posted:

Feb 18, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Congenital Hyperinsulinism

Nesidioblastosis

Hypoglycemia

Study Results

No Results Posted as of Feb 18, 2021