Brief description of trial (Data source: BASEC)
Bei einigen Personen besteht der Verdacht, dass es wiederkehrend zu erniedrigten Blutzuckerspiegeln kommt. Um diese Diagnose, zwecks Therapie, zu sichern wird aktuell ein Fastentest durchgeführt der maximal 72 Stunden dauern kann.
Mit dieser Studie wollen wir evaluieren, ob eine Exenatide Injektion den Fastentest ersetzen kann. Exenatide ist ein in der Schweiz bereits zugelassenes Medikament welches üblicherweise bei Patienten mit Diabetes eingesetzt wird.
In einigen vorausgegangenen Studien haben wir festgestellt, dass Exenatide in Patienten mit Verdacht auf wiederkehrend erniedrigte Blutzuckerspiegel die Diagnose sehr früh sicher kann.
Health conditions investigated(Data source: BASEC)
endogene hyperinsulinäme Hypoglykämie
Health conditions
(Data source: WHO)
Endogenous Hyperinsulinism
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Intravenöse Gabe von Exenatide
Interventions
(Data source: WHO)
Drug: Exenatide;Drug: 0.9% saline solution
Criteria for participation in trial
(Data source: BASEC)
Sie dürfen an der Studie teilnehmen wenn:
A) bei Ihnen die Diagnose einer endogenen hyperinsulinämen Hypoglykämie mittels eines Tests gesichert wurde.
B) bei Ihnen die Diagnose einer endogenen hyperinsulinämen Hypoglykämie mittels eines Tests ausgeschlossen wurde.
Zudem müssen sie älter als 18 Jahre sein und die Patientin-Einwilligung unterschrieben haben.
Exclusion criteria
(Data source: BASEC)
Wenn eine der folgenden Situationen vorliegt dürfen sie nicht an der Studie teilnehmen:
a) Bekannte Hypersensitivität oder Allergie zu Exenatide
b) Schwangerschaft oder Stillen
c) Bekannte Niereninsuffizienz (Kreatinin-Clearance < 40 ml/min)
d) Einnahme von Byetta® or Bydureon®
e) Diabetes mellitus
f) Einnahme von blutgerinnungshemmender Medikation
g) Jeglicher schwerkontrollierbarer medizinischer, psychiatrischer oder postoperativer Zustand
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Patients with suspicion for an insulinoma fulfilling all of the following inclusion
criteria are eligible for the study:
Inclusion Criteria:
- Informed Consent as documented by signature
- Biochemically proven endogenous hyperinsulinemic hypoglycemia: neuroglycopenic
symptoms in the fasting state with low plasma glucose, inappropriately high serum
insulin and C-peptide concentrations (standardized 72h fasting test).).
Participants as control subjects fulfilling all of the following inclusion criteria are
eligible for the study:
Inclusion Criteria:
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Possession of the adequate match criteria (age, BMI and gender) to patients with
suspicion for an insulinoma
Exclusion Criteria:
- Known hypersensitivity or allergy to Exenatide
- Pregnant or breastfeeding female patients. A pregnancy test will be performed in all
women of child bearing potential.
- Calculated creatinine clearance below 40 ml/min
- No signed informed consent
- Intake of any glucagon-like peptide (GLP)-1 analogue (such as Byetta? or Bydureon?[=
Exenatide])
- prediabetes or diabetes (HbA1c > 5.7 %)
- Previous abdominal surgery in the gastrointestinal tract
- Any concomitant glucose-lowering drug (i. e. insulin, sulfonyl urea)
- Any known intolerance to standardized meal (Maizena)
- Any uncontrolled significant medical, psychiatric or surgical condition (active
infection, unstable angina pectoris, cardiac arrhythmia, poorly controlled
hypertension, uncontrolled congestive heart disease, etc.) or laboratory findings that
might jeopardize the patient's safety or that would limit compliance with the
objectives and assessments of the study.
- Any mental conditions which prevent the patient from understanding the type, extent
and possible consequences of the study and/or an uncooperative attitude from the
patient
-
Further information on trial
Recruitment status
Completed
Academic title
(Data source: WHO)
Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
time to symptomatic hypoglycemia after exenatide test compared to placebo
Secundary end point
(Data source: WHO)
time dependent decrease (time ? from injection in min) of blood glucose (% or mmol/l));time to symptoms;time to hypoglycemia (time to reach blood sugar level = 2.5 mmol/l) in the exenatide test in comparison to the placebo;time to hypoglycemia (time to reach blood sugar level = 2.5 mmol/l) in the exenatide test in comparison to the fasting test;time to symptoms in the exenatide test in comparison to the fasting test;change in levels of plasma glucose compared to placebo compared to placebo;change in levels of insulin compared to placebo;change in levels of C-peptide compared to placebo;change in levels of proinsulin compared to placebo;change in levels of ?-hydroxybutyrate compared to placebo;costs of exenatide test setting (CHF)
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Basel
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Dr. Kwadwo Antwi
+41613286684
Kwadwo.Antwi@claraspital.ch
Contact for general information
(Data source: WHO)
Emanuel Christ, Prof. Dr. med.
University Hospital of Basel, Interdisciplinary Endocrinology
Contact for scientific information
(Data source: WHO)
Emanuel Christ, Prof. Dr. med.
University Hospital of Basel, Interdisciplinary Endocrinology
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
Date of authorisation by the ethics committee
12.06.2020
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2020-00169
Secondary ID (Data source: WHO)
qu20Antwi2
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