Idiopathic Ketotic Hypoglycemia
Conditions
Keywords
Idiopathic ketotic hypoglycemia, Glucose metabolism, Gut homones, Amino acids, Glucagon, Insulin, Continuous glucose monitor, CGM, Oral glucose tolerance test, Mixed meal test
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.
Interventions
BIOLOGICALOral glucose tolerance test
Consumption of 75 grams of glucose, diluted in water, added 1,5 g of acetaminophen.
BIOLOGICALMixed meal test
Consumption of a standardized liquid meal, with caloric and dietary content equal to a standard meal.
Sponsors
Odense University Hospital
University Hospital, Gentofte, Copenhagen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
A case-control intervention study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma glucose | -120, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes | The intergroup difference in peak to nadir difference in plasma glucose following OGTT/MMT |
| Time in range (CGM) | 0-14 days of CGM-period | The intergroup difference in time spend in glycemic range, measured by CGM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose revomal | -120, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes | Rate of disappearance of glucose, measured by tracer dilution technique |
| Amino acids | -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes | Plasma concentrations of amino acids |
| Insulin | -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes | Plasma concentrations of insulin |
| Glucagon like peptide-1 (GLP-1) | -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes | Plasma concentrations of GLP-1 |
| Glucagon | -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes | Plasma concentrations of glucagon |
| Coefficients of variation (CV) of plasma glucose | 0-14 days of CGM-period | CV of plasma glucose measured by CGM |
| Mean plasma glucose | 0-14 days of CGM-period | Average value of plasma glucose measured by CGM |
| Risk of hypoglycemia | 0-14 days of CGM-period | Time spend in hypoglycemia measured by CGM |
| Glucose-dependent insulinotropic polypeptide (GIP) | -120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes | Plasma concentrations of GIP |
| Endogenous glucose production | -120,, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes | Rate of appearance of glucose, measured by tracer dilution technique |
Countries
Denmark
Outcome results
None listed