Understanding Hypoglycaemia After Bariatric Surgery (HYPOBAR1)

December 3, 2018 updated by: University Hospital Inselspital, Berne

Exploring Beta Cell Function in Individuals With Postbariatric Postprandial

Postprandial hyperinsulinaemic hypoglycaemia is an increasingly recognized adverse side effect of bariatric surgery. Affected individuals experience low glucose levels 1-3 hours after intake of meals, accompanied by symptoms such as drowsiness, sweating, hunger and palpitations. Hypoglycaemia can be serious and have potential dangerous health impact (e.g. road accident or fall due to loss of consciousness). The pathophysiology is incompletely understood and more research is needed in search of preventive and therapeutic strategies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Obesity is a major global health concern that is associated with significant disability and mortality. Worldwide, the prevalence of obesity has doubled since 1980, affecting 13% of the global population. Bariatric surgery has been shown to be the most effective and durable treatment of severe obesity and leads to significant improvement of obesity-related comorbidity. However, postprandial hyperinsulinaemic hypoglycaemia (PHH) after bariatric surgery is a metabolic complication that is increasingly being recognized. Prevalence rates of up to 72% have been reported. PHH may have serious implications for affected patients, including negative effects on morbidity, mortality as well as quality of life. The pathophysiology of PPH is incompletely understood and suggests decreased adaptation of beta cell function to increased insulin sensitivity. The latter has been postulated to be largely secondary due to external factors outside the beta cells as a result of anatomical and hormonal changes after Roux-en-Y gastric bypass (RYGB). However, the intrinsic mechanistic effects of altered beta-cell function after RYGB in vivo are unknown and more exploration could lead to a better understanding of PHH pathogenesis and help identify targets for possible interventions. Previous studies performed enhanced beta cell analysis by following insulin synthesis in real-time based on stable isotope labelling of C-peptide during an oral glucose tolerance test (OGTT) in cohorts with normal and diabetic glucose tolerance. Applying the same methodological approach, albeit in a different target population (PPH after bariatric surgery), the present study seeks to explore whether or not the insulin hypersecretion can be explained by an increase in insulin synthesis, and secondly, whether potentially increased insulin synthesis can be related to other glucoregulatory hormones and measures of insulin sensitivity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gastric bypass (RYGB) surgery performed ≥ 6 months ago
  • Confirmed postprandial hypoglycaemia (continuous glucose monitoring or plasma glucose), with at least 2 episodes of Whipple's triad (symptoms, capillary of interstitial glucose ≤3.1mmol/L, symptom resolution by carbohydrate intake) ≤3 months ago
  • Normal glucose control at recruitment and absence of (pre)diabetes before bariatric surgery
  • Capacity to give informed consent

Exclusion Criteria:

  • Fasting hypoglycaemia suggesting hyperinsulinism of different aetiology
  • Use of medication that influence glucose metabolism
  • Bariatric procedures other than RYGB
  • Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
  • Moderate to severe chronic kidney disease
  • Pregnancy or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: OGTT with 13C-labelled leucine
Intake of 75g of glucose with 1g of 13C leucine pre-feeding
Other: Dietary Supplement: Glucose
Intake of 75g of glucose with 1g of 13C leucine pre-feeding

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fractional synthesis rate of de novo C-peptide synthesis (%/hr)
Time Frame: 4.5 hours
Calculated
4.5 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
C-peptide levels in blood
Time Frame: 4.5 hours
Measured
4.5 hours
Insulin levels in blood
Time Frame: 4.5 hours
Measured
4.5 hours
Glucagon levels in blood
Time Frame: 4.5 hours
Measured
4.5 hours
Incretin levels in blood
Time Frame: 4.5 hours
Measured
4.5 hours
Insulin sensitivity
Time Frame: 4.5 hours
Calculated
4.5 hours
Beta cell responsivity
Time Frame: 4.5 hours
Calculated
4.5 hours
Hepatic insulin extraction
Time Frame: 4.5 hours
Calculated
4.5 hours
C-peptide levels in urine
Time Frame: 4.5 hours
Measured
4.5 hours
C-peptide enrichment
Time Frame: 4.5 hours
calculated
4.5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Inselspital, Berne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Erasmus Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christoph Stettler, MD, Inselspital, Bern University Hospital, University of Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 2, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 2, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HYPOBAR1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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