A Glucometabolic Evaluation of Patients With Idiopathic Ketotic Hypoglycemia

NCT ID: NCT05310292

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-21
• Study Completion Date: 2025-04-01

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.

Conditions

Idiopathic Ketotic Hypoglycemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Subjects diagnosed with IKH

10 patients, diagnosed with IKH

Group Type: EXPERIMENTAL

Oral glucose tolerance test

Intervention Type: BIOLOGICAL

Consumption of 75 grams of glucose, diluted in water, added 1,5 g of acetaminophen.

Mixed meal test

Intervention Type: BIOLOGICAL

Consumption of a standardized liquid meal, with caloric and dietary content equal to a standard meal.

Healthy control subjects

10 subjects, healthy, matched for gender, BMI, age

Group Type: EXPERIMENTAL

Oral glucose tolerance test

Intervention Type: BIOLOGICAL

Consumption of 75 grams of glucose, diluted in water, added 1,5 g of acetaminophen.

Mixed meal test

Intervention Type: BIOLOGICAL

Consumption of a standardized liquid meal, with caloric and dietary content equal to a standard meal.

Interventions

Oral glucose tolerance test

Consumption of 75 grams of glucose, diluted in water, added 1,5 g of acetaminophen.

Intervention Type: BIOLOGICAL

Mixed meal test

Consumption of a standardized liquid meal, with caloric and dietary content equal to a standard meal.

Intervention Type: BIOLOGICAL

Other Intervention Names

OGTT; MMT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Odense University Hospital

OTHER

Sponsor Role: collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Magnus Frederik Gluud Grøndahl

Principal investigator, Medical Doctor, PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Center for Clinical Metabolic Research, Department of Medicine, Gentofte Hospital

Hellerup, Copenhagen, Denmark

Countries

Denmark

Other Identifiers

H-21056987

Identifier Type: -

Identifier Source: org_study_id