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

Primary Purpose

Idiopathic Ketotic Hypoglycemia

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Oral glucose tolerance test
Mixed meal test
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Idiopathic Ketotic Hypoglycemia focused on measuring Idiopathic ketotic hypoglycemia, Glucose metabolism, Gut homones, Amino acids, Glucagon, Insulin, Continuous glucose monitor, CGM, Oral glucose tolerance test, Mixed meal test

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Subjects diagnosed with IKH

Healthy control subjects

Arm Description

10 patients, diagnosed with IKH

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

Outcomes

Primary Outcome Measures

Plasma glucose
The intergroup difference in peak to nadir difference in plasma glucose following OGTT/MMT
Time in range (CGM)
The intergroup difference in time spend in glycemic range, measured by CGM

Secondary Outcome Measures

Endogenous glucose production
Rate of appearance of glucose, measured by tracer dilution technique
Glucose revomal
Rate of disappearance of glucose, measured by tracer dilution technique
Amino acids
Plasma concentrations of amino acids
Insulin
Plasma concentrations of insulin
Glucagon
Plasma concentrations of glucagon
Glucagon like peptide-1 (GLP-1)
Plasma concentrations of GLP-1
Glucose-dependent insulinotropic polypeptide (GIP)
Plasma concentrations of GIP
Coefficients of variation (CV) of plasma glucose
CV of plasma glucose measured by CGM
Mean plasma glucose
Average value of plasma glucose measured by CGM
Risk of hypoglycemia
Time spend in hypoglycemia measured by CGM

Full Information

First Posted
March 25, 2022
Last Updated
May 11, 2023
Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05310292
Brief Title
A Glucometabolic Evaluation of Patients With Idiopathic Ketotic Hypoglycemia
Acronym
IKH_MetEx
Official Title
A Glucometabolic Evaluation of Patients With Idiopathic Ketotic Hypoglycemia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Odense University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Ketotic Hypoglycemia
Keywords
Idiopathic ketotic hypoglycemia, Glucose metabolism, Gut homones, Amino acids, Glucagon, Insulin, Continuous glucose monitor, CGM, Oral glucose tolerance test, Mixed meal test

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A case-control intervention study.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subjects diagnosed with IKH
Arm Type
Experimental
Arm Description
10 patients, diagnosed with IKH
Arm Title
Healthy control subjects
Arm Type
Experimental
Arm Description
10 subjects, healthy, matched for gender, BMI, age
Intervention Type
Biological
Intervention Name(s)
Oral glucose tolerance test
Other Intervention Name(s)
OGTT
Intervention Description
Consumption of 75 grams of glucose, diluted in water, added 1,5 g of acetaminophen.
Intervention Type
Biological
Intervention Name(s)
Mixed meal test
Other Intervention Name(s)
MMT
Intervention Description
Consumption of a standardized liquid meal, with caloric and dietary content equal to a standard meal.
Primary Outcome Measure Information:
Title
Plasma glucose
Description
The intergroup difference in peak to nadir difference in plasma glucose following OGTT/MMT
Time Frame
-120, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Title
Time in range (CGM)
Description
The intergroup difference in time spend in glycemic range, measured by CGM
Time Frame
0-14 days of CGM-period
Secondary Outcome Measure Information:
Title
Endogenous glucose production
Description
Rate of appearance of glucose, measured by tracer dilution technique
Time Frame
-120,, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Title
Glucose revomal
Description
Rate of disappearance of glucose, measured by tracer dilution technique
Time Frame
-120, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Title
Amino acids
Description
Plasma concentrations of amino acids
Time Frame
-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Title
Insulin
Description
Plasma concentrations of insulin
Time Frame
-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Title
Glucagon
Description
Plasma concentrations of glucagon
Time Frame
-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Title
Glucagon like peptide-1 (GLP-1)
Description
Plasma concentrations of GLP-1
Time Frame
-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Title
Glucose-dependent insulinotropic polypeptide (GIP)
Description
Plasma concentrations of GIP
Time Frame
-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Title
Coefficients of variation (CV) of plasma glucose
Description
CV of plasma glucose measured by CGM
Time Frame
0-14 days of CGM-period
Title
Mean plasma glucose
Description
Average value of plasma glucose measured by CGM
Time Frame
0-14 days of CGM-period
Title
Risk of hypoglycemia
Description
Time spend in hypoglycemia measured by CGM
Time Frame
0-14 days of CGM-period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Center for Clinical Metabolic Research, Department of Medicine, Gentofte Hospital
City
Hellerup
State/Province
Copenhagen
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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A Glucometabolic Evaluation of Patients With Idiopathic Ketotic Hypoglycemia

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