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

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: Active, not recruiting
• Conditions: Idiopathic Ketotic Hypoglycemia
• Intervention / Treatment: Biological: Oral glucose tolerance test; Biological: Mixed meal test

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: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Plasma glucose	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)	The intergroup difference in time spend in glycemic range, measured by CGM	0-14 days of CGM-period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endogenous glucose production	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	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	Plasma concentrations of amino acids	-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Insulin	Plasma concentrations of insulin	-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Glucagon	Plasma concentrations of glucagon	-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Glucagon like peptide-1 (GLP-1)	Plasma concentrations of GLP-1	-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Glucose-dependent insulinotropic polypeptide (GIP)	Plasma concentrations of GIP	-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	0-14 days of CGM-period
Mean plasma glucose	Average value of plasma glucose measured by CGM	0-14 days of CGM-period
Risk of hypoglycemia	Time spend in hypoglycemia measured by CGM	0-14 days of CGM-period

Collaborators and Investigators

• Sponsor: University Hospital, Gentofte, Copenhagen
• Collaborators: Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: March 25, 2022
• First Submitted That Met QC Criteria: March 25, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Insulin; CGM; Oral glucose tolerance test; Glucagon; Glucose metabolism; Amino acids; Continuous glucose monitor; Idiopathic ketotic hypoglycemia; Gut homones; Mixed meal test
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia
• Other Study ID 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