Clinical trial NCT05310292: A Glucometabolic Evaluation of Patients With Idiopathic Ketotic Hypoglycemia
Official title: A Glucometabolic Evaluation of Patients With Idiopathic Ketotic Hypoglycemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Ketotic Hypoglycemia
Keywords: Idiopathic ketotic hypoglycemia
Glucose metabolism
Gut homones
Amino acids
Glucagon
Insulin
Continuous glucose monitor
CGM
Oral glucose tolerance test
Mixed meal test
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2022-04-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A case-control intervention study.
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Plasma glucose
timeFrame: -120, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
measure: Time in range (CGM)
timeFrame: 0-14 days of CGM-period
Secondary outcomes:
measure: Endogenous glucose production
timeFrame: -120,, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
measure: Glucose revomal
timeFrame: -120, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
measure: Amino acids
timeFrame: -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
measure: Insulin
timeFrame: -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
measure: Glucagon
timeFrame: -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
measure: Glucagon like peptide-1 (GLP-1)
timeFrame: -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
measure: Glucose-dependent insulinotropic polypeptide (GIP)
timeFrame: -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
measure: Coefficients of variation (CV) of plasma glucose
timeFrame: 0-14 days of CGM-period
measure: Mean plasma glucose
timeFrame: 0-14 days of CGM-period
measure: Risk of hypoglycemia
timeFrame: 0-14 days of CGM-period
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Center for Clinical Metabolic Research, Department of Medicine, Gentofte Hospital
state: Copenhagen
Study officials:
References: