Clinical trial NCT06182527: Relevance of Reactive Hypoglycemia During an OGTT in Everyday Life Using Continuous Glucose Measurement
Official title: Evaluation of the Everyday Relevance of Reactive Hypoglycemia in the Oral Glucose Tolerance Test Using Continuous Glucose Measurement.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypoglycemia, Reactive
Keywords: Reactive Hypoglycemia
Oral glucose tolerance test
Continuous glucose monitoring
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This research project aims to investigate the everyday relevance of reactive hypoglycemia (hypoglycemia after a glucose load) in the oral glucose tolerance test (OGTT). Therefore, blood glucose profiles in everyday life will be examined using continuous glucose measurement (Free Style Libre PRO IQ system) over a period of 14 days in affected persons.

Detailed description: The aim of this analysis is to examine people who underwent an OGTT due to various endocrinological and metabolic issues and developed reactive hypoglycemia, defined as a drop in blood glucose \<70mg/dl during the course of the test. During OGTT routine laboratory testing will be performed as part of routine clinical practice. In order to investigate the occurrence and perception of hypoglycaemia in the everyday lives of those affected, their blood glucose profiles will be recorded and evaluated over a period of 14 days.

In addition, the perception of (suspected) hypoglycemia and counteraction will be documented. Anthropometric data will be recorded and a bioelectrical impedance analysis performed to check a correlation with the body composition. Subjects will be recruited via the endocrinology outpatient clinic as part of medical care. To date, very little CGM data are available on the frequency and extent of reactive hypoglycemia in the everyday lives of people without diabetes mellitus. Therefore, 20 subjects with hypoglycemia in the OGTT will be included in this exploratory pilot study for hypothesis generation in order to investigate the occurrence and perception of hypoglycemia in everyday life.

Eligibility criteria: Inclusion Criteria:

* hypoglycemia during a 75 g oral glucose tolerance test defined as glucose level below 70 mg/dl at timepoint 180 min.
* written consent

Exclusion Criteria:

* diabetes mellitus
* use of medication interfering with glucose metabolism (steroid, antidiabetic medications)
* surgery of upper GI-tract
* known plaster allergies
* any other clinical condition that would endanger participants safety or question scientific success according to the physicians opinion

Primary outcomes:
measure: Occurrence of hypoglycemia
timeFrame: 14 days
measure: Frequency of hypoglycemia
timeFrame: 14 days
measure: Severity of hypoglycemia
timeFrame: 14 days
Secondary outcomes:
measure: Time of occurence of hypoglycemia
timeFrame: 14 days
measure: Perception of hypoglycemia
timeFrame: 14 days
measure: Time in predefined glucose ranges
timeFrame: 14 days
measure: Mean glucose levels
timeFrame: 14 days
measure: Glucose variability
timeFrame: 14 days
measure: Correlation between severity of hypoglycemia during ogtt and hypoglycemia in everyday life
timeFrame: Varying time point between oGTT and 14 days of glucose assessment using CGM
measure: Correlation between body composition and hypoglycemia in everyday life
timeFrame: 14 days
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Universityhospital Ulm
Study officials:
affiliation: University Hospital Ulm
name: Martin Heni, Prof.
role: PRINCIPAL_INVESTIGATOR
References: