A Glucometabolic Evaluation of Patients With Idiopathic Ketotic Hypoglycemia (IKH_MetEx)

May 11, 2023 updated by: Magnus Frederik Gluud Grøndahl, University Hospital, Gentofte, Copenhagen
The project will evaluate 1) the postprandial metabolism and 2) continuous glucose levels in subjects diagnosed with Idiopathic Ketotic Hypoglycemia (IKH)) and healthy control subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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

IKH is a common, but not fully understood, condition in children, and in some the condition may persist in adulthood. In the present study we seek to evaluate the postprandial metabolism in adult subjects diagnosed with IKH through a clinical study including:

  1. two test days, where the subjects completes a) an oral glucose tolerance test (OGTT) and b) a miced meal test (MMT). Before, during and after ingestion of the OGTT/MMT, blood samples will be frequently drawn for the evaluation of plasma glucose, hormones, amino acids and more. During both tests, the subjects will recieve a continuous infusion of primed glucose tracer to further evaluate the glucose metabolism.
  2. a 14-day period where the subjects will lead the usual lives, wearing a continuous glucose monitor (CGM). This will enable us to evaluate long-term differences in plasma glucose levels in IKH.

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 (Anticipated)

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.
20

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

  • Denmark
    • Copenhagen
      • Hellerup, Copenhagen, Denmark, 2900
        • Center for Clinical Metabolic Research, Department of Medicine, Gentofte 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • IKH-participants:
  • Verified diagnosis of IKH by health professional
  • BMI of 18-30 kg/m2
  • Normal liver- and kidney function
  • informed consent

Healthy control participants

  • Normal glucose tolerance
  • BMI of 18-30 kg/m2
  • Normal liver- and kidney function
  • informed consent

Exclusion Criteria:

  • A history of diabetes
  • close family members with diabetes
  • use of drugs affecting the glucose metabolism that cannot be paused
  • anemia
  • any condition that the study investigators deem unacceptable for participation
  • 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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel 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: Subjects diagnosed with IKH
10 patients, diagnosed with IKH
Biological: Oral glucose tolerance test
Consumption of 75 grams of glucose, diluted in water, added 1,5 g of acetaminophen.
Other Names:
  • OGTT
Biological: Mixed meal test
Consumption of a standardized liquid meal, with caloric and dietary content equal to a standard meal.
Other Names:
  • MMT
Experimental: Healthy control subjects
10 subjects, healthy, matched for gender, BMI, age
Biological: Oral glucose tolerance test
Consumption of 75 grams of glucose, diluted in water, added 1,5 g of acetaminophen.
Other Names:
  • OGTT
Biological: Mixed meal test
Consumption of a standardized liquid meal, with caloric and dietary content equal to a standard meal.
Other Names:
  • MMT

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
Plasma glucose
Time Frame: -120, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
The intergroup difference in peak to nadir difference in plasma glucose following OGTT/MMT
-120, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Time in range (CGM)
Time Frame: 0-14 days of CGM-period
The intergroup difference in time spend in glycemic range, measured by CGM
0-14 days of CGM-period

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
Endogenous glucose production
Time Frame: -120,, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Rate of appearance of glucose, measured by tracer dilution technique
-120,, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Glucose revomal
Time Frame: -120, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Rate of disappearance of glucose, measured by tracer dilution technique
-120, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Amino acids
Time Frame: -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Plasma concentrations of amino acids
-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Insulin
Time Frame: -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Plasma concentrations of insulin
-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Glucagon
Time Frame: -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Plasma concentrations of glucagon
-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Glucagon like peptide-1 (GLP-1)
Time Frame: -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Plasma concentrations of GLP-1
-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Glucose-dependent insulinotropic polypeptide (GIP)
Time Frame: -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Plasma concentrations of GIP
-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Coefficients of variation (CV) of plasma glucose
Time Frame: 0-14 days of CGM-period
CV of plasma glucose measured by CGM
0-14 days of CGM-period
Mean plasma glucose
Time Frame: 0-14 days of CGM-period
Average value of plasma glucose measured by CGM
0-14 days of CGM-period
Risk of hypoglycemia
Time Frame: 0-14 days of CGM-period
Time spend in hypoglycemia measured by CGM
0-14 days of CGM-period

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, Gentofte, Copenhagen

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.
Odense University Hospital

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.
March 21, 2022

Primary Completion (Anticipated)

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.
April 1, 2024

Study Completion (Anticipated)

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.
April 1, 2025

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).
March 25, 2022

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.
March 25, 2022

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.
April 4, 2022

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.
May 12, 2023

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.
May 11, 2023

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.
May 1, 2023

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.
  • H-21056987

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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