Effect of Postprandial Hyperinsulinaemic Hypoglycaemia on Driving Performance.

NCT04330196 | Completed DMC

• 1 other identifier: DEEP1C
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Roux-en-Y Gastric Bypass; Postprandial Hypoglycemia; Driving Impaired

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Hypoglycemic symptoms over the glycemic trajectory after glucose vs. aspartame intake

  From -15 to 180 minutes after glucose/aspartame intake

• Cognitive test performance after glucose vs. aspartame intake

  135 minutes after glucose/aspartame intake

Other Outcomes (2)

• Time course of the hormonal response after glucose/aspartame intake

  From -15 to 120 minutes after glucose/aspartame intake

• Heart rate after glucose/aspartame intake

  From -15 to 180 minutes after glucose/aspartame intake

Study Arms (2)

Glucose condition

EXPERIMENTAL

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

Diagnostic Test: Oral glucose tolerance test

Control condition

PLACEBO COMPARATOR

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

Diagnostic Test: Ingestion of placebo

Interventions

Oral glucose tolerance test DIAGNOSTIC_TEST

Participant ingests 75g of glucose

Glucose condition

Ingestion of placebo DIAGNOSTIC_TEST

Participant ingests 700mg of aspartame

Control condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years
• Roux-en-Y gastric bypass ≥1 year ago

You may not qualify if:

• 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

Sponsors & Collaborators

• Lia Bally: lead

Study Sites (1)

Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Hypoglycemia

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Lia Bally, MD, PhD

  University Hopsital Bern, University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 1, 2020
• Study Start: July 8, 2020
• Primary Completion: December 3, 2020
• Study Completion: December 3, 2020
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)