NCT05310292

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

March 25, 2022

Last Update Submit

May 11, 2023

Conditions

Idiopathic Ketotic Hypoglycemia

Keywords

Idiopathic ketotic hypoglycemiaGlucose metabolismGut homonesAmino acidsGlucagonInsulinContinuous glucose monitorCGMOral glucose tolerance testMixed meal test

Outcome Measures

Primary Outcomes (2)

  • Plasma glucose

    The intergroup difference in peak to nadir difference in plasma glucose following OGTT/MMT

    -120, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes

  • Time in range (CGM)

    The intergroup difference in time spend in glycemic range, measured by CGM

    0-14 days of CGM-period

Secondary Outcomes (10)

  • Endogenous glucose production

    -120,, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes

  • Glucose revomal

    -120, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes

  • Amino acids

    -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes

  • Insulin

    -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes

  • Glucagon

    -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes

  • +5 more secondary outcomes

Study Arms (2)

Subjects diagnosed with IKH

EXPERIMENTAL

10 patients, diagnosed with IKH

Biological: Oral glucose tolerance testBiological: Mixed meal test

Healthy control subjects

EXPERIMENTAL

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

Biological: Oral glucose tolerance testBiological: Mixed meal test

Interventions

Oral glucose tolerance testBIOLOGICAL

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

Also known as: OGTT
Healthy control subjectsSubjects diagnosed with IKH
Mixed meal testBIOLOGICAL

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

Also known as: MMT
Healthy control subjectsSubjects diagnosed with IKH

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hellerup, Copenhagen, 2900, Denmark

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Glucose Tolerance Test2-methylcyclopentadienyl manganese tricarbonyl

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: A case-control intervention study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Medical Doctor, PhD student

Study Record Dates

First Submitted

March 25, 2022

First Posted

April 4, 2022

Study Start

March 21, 2022

Primary Completion

April 1, 2024

Study Completion

April 1, 2025

Last Updated

May 12, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)