An interventional study of Oral glucose tolerance test and Mixed meal test in Idiopathic Ketotic Hypoglycemia, sponsored by University Hospital, Gentofte, Copenhagen. Active, not recruiting at 1 site in Denmark. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-12.
Sponsored by University Hospital, Gentofte, Copenhagen · Not applicable, Interventional, and Basic science
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.
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:
640 studies on the registry are indexed under Hypoglycemia; 86 are open to participants now.
This study's planned enrollment of 20 is below the median of 29 across 471 interventional studies indexed under Hypoglycemia.
Browse Hypoglycemia studies →University Hospital, Gentofte, Copenhagen is the lead sponsor of 154 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy control participants
Exclusion Criteria:
10 patients, diagnosed with IKH
Biological: Oral glucose tolerance test · Biological: Mixed meal test
10 subjects, healthy, matched for gender, BMI, age
Biological: Oral glucose tolerance test · Biological: Mixed meal test
Consumption of 75 grams of glucose, diluted in water, added 1,5 g of acetaminophen.
Also known as: OGTT
Consumption of a standardized liquid meal, with caloric and dietary content equal to a standard meal.
Also known as: MMT
Plasma glucose
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
Time in range (CGM)
The intergroup difference in time spend in glycemic range, measured by CGM
Time frame: 0-14 days of CGM-period
Endogenous glucose production
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
Glucose revomal
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
Amino acids
Plasma concentrations of amino acids
Time frame: -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Insulin
Plasma concentrations of insulin
Time frame: -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Glucagon
Plasma concentrations of glucagon
Time frame: -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Glucagon like peptide-1 (GLP-1)
Plasma concentrations of GLP-1
Time frame: -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Glucose-dependent insulinotropic polypeptide (GIP)
Plasma concentrations of GIP
Time frame: -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Coefficients of variation (CV) of plasma glucose
CV of plasma glucose measured by CGM
Time frame: 0-14 days of CGM-period
Mean plasma glucose
Average value of plasma glucose measured by CGM
Time frame: 0-14 days of CGM-period
Risk of hypoglycemia
Time spend in hypoglycemia measured by CGM
Time frame: 0-14 days of CGM-period
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Gentofte, Copenhagen