Idiopathic Ketotic HypoglycemiaIKH_MetExNCT05310292
A Glucometabolic Evaluation of Patients With Idiopathic Ketotic Hypoglycemia
A study testing Oral glucose tolerance test and Mixed meal test in people with Idiopathic Ketotic Hypoglycemia, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Ketotic Hypoglycemia
- What is being tested?
- Oral glucose tolerance test and Mixed meal test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Mar 2022to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Normal glucose tolerance
- BMI of 18-30 kg/m2
- Normal liver- and kidney function
- informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Clinical Metabolic Research, Department of Medicine, Gentofte Hospital
Hellerup, Copenhagen, 2900
About this study
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.
Read the 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:
- 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.
- 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.
- Conditions
- Idiopathic Ketotic Hypoglycemia
- Being tested
- Oral glucose tolerance test, Mixed meal test
- Keywords
- Idiopathic ketotic hypoglycemia, Glucose metabolism, Gut homones, Amino acids, Glucagon, Insulin, Continuous glucose monitor, CGM, Oral glucose tolerance test, Mixed meal test
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose tolerance testBiological
Also called OGTT
Consumption of 75 grams of glucose, diluted in water, added 1,5 g of acetaminophen.
Mixed meal testBiological
Also called MMT
Consumption of a standardized liquid meal, with caloric and dietary content equal to a standard meal.
| Study group | Role | What they receive |
|---|---|---|
| Subjects diagnosed with IKH | Experimental | 10 patients, diagnosed with IKH Receives: Biological: Oral glucose tolerance test; Biological: Mixed meal test |
| Healthy control subjects | Experimental | 10 subjects, healthy, matched for gender, BMI, age Receives: Biological: Oral glucose tolerance test; Biological: Mixed meal test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose
The intergroup difference in peak to nadir difference in plasma glucose following OGTT/MMT
Measured: -120, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Time in range (CGM)
The intergroup difference in time spend in glycemic range, measured by CGM
Measured: 0-14 days of CGM-period
Secondary outcomes (10)
Endogenous glucose production
Rate of appearance of glucose, measured by tracer dilution technique
Measured: -120,, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Glucose revomal
Rate of disappearance of glucose, measured by tracer dilution technique
Measured: -120, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Amino acids
Plasma concentrations of amino acids
Measured: -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Insulin
Plasma concentrations of insulin
Measured: -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Glucagon
Plasma concentrations of glucagon
Measured: -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Glucagon like peptide-1 (GLP-1)
Plasma concentrations of GLP-1
Measured: -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Glucose-dependent insulinotropic polypeptide (GIP)
Plasma concentrations of GIP
Measured: -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Coefficients of variation (CV) of plasma glucose
CV of plasma glucose measured by CGM
Measured: 0-14 days of CGM-period
Mean plasma glucose
Average value of plasma glucose measured by CGM
Measured: 0-14 days of CGM-period
Risk of hypoglycemia
Time spend in hypoglycemia measured by CGM
Measured: 0-14 days of CGM-period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start21 Mar 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Ketotic HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A case-control intervention study.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Principal investigator, Magnus Frederik Gluud Grøndahl, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310292
- Sponsor's protocol ID
- H-21056987
- Acronym
- IKH_MetEx
- Status last verified
- May 2023
- First submitted
- 25 Mar 2022
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Glucometabolic Evaluation of Patients With Idiopathic Ketotic Hypoglycemia
- ClinicalTrials.gov ID
- NCT05310292
- Acronym / sponsor ID
- IKH_MetEx / H-21056987
- Conditions
- Idiopathic Ketotic Hypoglycemia
- Keywords
- Idiopathic ketotic hypoglycemia, Glucose metabolism, Gut homones, Amino acids, Glucagon, Insulin, Continuous glucose monitor, CGM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A case-control intervention study.
| Arm | Type | Receives |
|---|---|---|
| Subjects diagnosed with IKH | Experimental | Biological: Oral glucose tolerance test, Biological: Mixed meal test10 patients, diagnosed with IKH |
| Healthy control subjects | Experimental | Biological: Oral glucose tolerance test, Biological: Mixed meal test10 subjects, healthy, matched for gender, BMI, age |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- IKH-participants:
- Verified diagnosis of IKH by health professional
- BMI of 18-30 kg/m2
- Normal liver- and kidney function
- informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral glucose tolerance testAlso: OGTTConsumption of 75 grams of glucose, diluted in water, added 1,5 g of acetaminophen. | Biological | Healthy control subjects, Subjects diagnosed with IKH |
| Mixed meal testAlso: MMTConsumption of a standardized liquid meal, with caloric and dietary content equal to a standard meal. | Biological | Healthy control subjects, Subjects diagnosed with IKH |
Primary outcome
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
Time in range (CGM)
Time frame: 0-14 days of CGM-period
The intergroup difference in time spend in glycemic range, measured by CGM
10 secondary outcomes
Endogenous glucose production
Time frame: -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
Amino acids
Time frame: -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
Glucagon
Time frame: -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
Glucose-dependent insulinotropic polypeptide (GIP)
Time frame: -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
Mean plasma glucose
Time frame: 0-14 days of CGM-period
Risk of hypoglycemia
Time frame: 0-14 days of CGM-period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral glucose tolerance test and Mixed meal test in people with Idiopathic Ketotic Hypoglycemia, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma glucose (time frame: -120, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.