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Clinical trial

A Glucometabolic Evaluation of Patients With Idiopathic Ketotic Hypoglycemia

ID
Name
H-21056987
Description
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 arms
Trial start
2022-03-21
Estimated PCD
2024-04-01
Trial end
2025-04-01
Status
Active (not recruiting)
Treatment
Oral glucose tolerance test
Consumption of 75 grams of glucose, diluted in water, added 1,5 g of acetaminophen.
Arms:
Healthy control subjects, Subjects diagnosed with IKH
Other names:
OGTT
Mixed meal test
Consumption of a standardized liquid meal, with caloric and dietary content equal to a standard meal.
Arms:
Healthy control subjects, Subjects diagnosed with IKH
Other names:
MMT
Size
20
Primary endpoint
Plasma glucose
-120, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Time in range (CGM)
0-14 days of CGM-period
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A case-control intervention study.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}
Updated at
2023-05-12

1 organization

2 products

1 indication

Organization
University Hospital of Copenhagen
Product
Oral glucose tolerance test
Indication
Ketotic Hypoglycemia
Product
Mixed meal test