A Glucometabolic Evaluation of Patients With Idiopathic Ketotic Hypoglycemia

Not Applicable

Active, not recruiting

• Conditions: Idiopathic Ketotic Hypoglycemia
• Interventions: Biological: Oral glucose tolerance test; Biological: Mixed meal test

• Registration Number: NCT05310292
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

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.

Study Timeline

• Study Start: 2022-03-21
• Study First Submitted: 2022-03-25
• Study First Submitted QC: 2022-03-25
• Study First Posted: 2022-04-04
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-12
• Primary Completion: 2024-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy control subjects	Oral glucose tolerance test	10 subjects, healthy, matched for gender, BMI, age
Healthy control subjects	Mixed meal test	10 subjects, healthy, matched for gender, BMI, age
Subjects diagnosed with IKH	Mixed meal test	10 patients, diagnosed with IKH
Subjects diagnosed with IKH	Oral glucose tolerance test	10 patients, diagnosed with IKH

Primary Outcome Measures

Name	Time	Method
Plasma glucose	-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)	0-14 days of CGM-period	The intergroup difference in time spend in glycemic range, measured by CGM

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Center for Clinical Metabolic Research, Department of Medicine, Gentofte Hospital; 🇩🇰 Hellerup, Copenhagen, Denmark