NCT05310292

A Glucometabolic Evaluation of Patients With Idiopathic Ketotic Hypoglycemia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University Hospital, Gentofte, Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Oral glucose tolerance test	Consumption of 75 grams of glucose, diluted in water, added 1,5 g of acetaminophen.
BIOLOGICAL	Mixed meal test	Consumption of a standardized liquid meal, with caloric and dietary content equal to a standard meal.

Timeline

• Start date: 2022-03-21
• Primary completion: 2024-04-01
• Completion: 2025-04-01
• First posted: 2022-04-04
• Last updated: 2023-05-12

Locations

1 site across 1 country: Denmark