Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-25 @ 7:28 PM
Study NCT ID:
NCT05310292
Status:
UNKNOWN
Last Update Posted:
2023-05-12
First Post:
2022-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Glucometabolic Evaluation of Patients With Idiopathic Ketotic Hypoglycemia
Sponsor:
University Hospital, Gentofte, Copenhagen
Organization:
Study Overview
Official Title:
A Glucometabolic Evaluation of Patients With Idiopathic Ketotic Hypoglycemia
Status:
UNKNOWN
Status Verified Date:
2023-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IKH_MetEx
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: