Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia (FAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04909333
Recruitment Status : Recruiting
First Posted : June 1, 2021
Last Update Posted : June 3, 2021
Sponsor:
Collaborator:
Gottfried und Julia Bangerter-Rhyner-Stiftung
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
This study is to evaluate the concept of the exenatide test for diagnosis of EHH (earlier induction of symptomatic hypoglycemia compared to placebo within 4 hours after injection).

Condition or disease Intervention/treatment Phase
Endogenous Hyperinsulinism Drug: Exenatide Drug: 0.9% saline solution Not Applicable

Detailed Description:

Endogenous hyperinsulinemic hypoglycemia (EHH) is defined as inappropriate endogenous insulin secretion leading to hypoglycemia and associated symptoms. The most frequent diagnosis is an insulin-secreting pancreatic neuroendocrine tumor, but other diagnoses such as nesidioblastosis of the pancreatic islets are also possible. Biochemically, EHH is characterized by low glucose concentrations in the presence of inappropriately increased C-peptide (endogenous insulin secretion) and insulin levels. The conventional fasting test is at present the gold standard to document EHH.

Radiolabeled Exenatide for localizing insulinomas in patients with biochemically proven EHH has been evaluated and an exenatide-test in an outpatient setting may be able to replace the fasting test, by an early symptomatic hypoglycemia compared to a prolonged inpatient monitoring.

This study is to investigate the concept of the exenatide test to diagnose EHH.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia
Actual Study Start Date : April 29, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023


Arm Intervention/treatment
Experimental: Group A (EHH Patients)
Group A will receive a placebo injection (0.9% saline solution) on Day 1 and 10μg Exenatide injection on Day 2.
Drug: Exenatide

Day1: After a standardized night meal (Maizena 40g plus dessert) at 22 p.m. on the day before, patients receive Exenatide study medication according to the randomization list (injection done slowly over 5 min.). Regular clinical examination of vegetative and neurological state will be done as well as continuous blood sugar measurements and blood withdrawals will be performed.

Day2:

The procedure is equal to study day 1. Instead of Exenatide a 10ml 0.9% saline solution, will be administered intravenously.

Other Name: Day 1 Exenatide; Day 2 : 0.9% saline solution

Drug: 0.9% saline solution

Day1: After a standardized night meal (Maizena 40g plus dessert) at 22 p.m. on the day before, patients receive 0.9% saline solution according to the randomization list (injection done slowly over 5 min.). Regular clinical examination of vegetative and neurological state will be done as well as continuous blood sugar measurements and blood withdrawals will be performed.

Day2:

The procedure is equal to study day 1. Instead of 0.9% saline solution, Exenatide will be administered intravenously.

Other Name: Day 1 : 0.9% saline solution, Day 2 Exenatide

Experimental: Group B (EHH Patients)
Group B will receive a 10μg Exenatide injection on Day 1 and placebo injection (0.9% saline solution) on Day 2.
Drug: Exenatide

Day1: After a standardized night meal (Maizena 40g plus dessert) at 22 p.m. on the day before, patients receive Exenatide study medication according to the randomization list (injection done slowly over 5 min.). Regular clinical examination of vegetative and neurological state will be done as well as continuous blood sugar measurements and blood withdrawals will be performed.

Day2:

The procedure is equal to study day 1. Instead of Exenatide a 10ml 0.9% saline solution, will be administered intravenously.

Other Name: Day 1 Exenatide; Day 2 : 0.9% saline solution

Drug: 0.9% saline solution

Day1: After a standardized night meal (Maizena 40g plus dessert) at 22 p.m. on the day before, patients receive 0.9% saline solution according to the randomization list (injection done slowly over 5 min.). Regular clinical examination of vegetative and neurological state will be done as well as continuous blood sugar measurements and blood withdrawals will be performed.

Day2:

The procedure is equal to study day 1. Instead of 0.9% saline solution, Exenatide will be administered intravenously.

Other Name: Day 1 : 0.9% saline solution, Day 2 Exenatide




Primary Outcome Measures :
  1. time to symptomatic hypoglycemia after exenatide test compared to placebo [ Time Frame: within 4 hours after injection ]
    time to symptomatic hypoglycemia after exenatide test compared to placebo


Secondary Outcome Measures :
  1. time dependent decrease (time Δ from injection in min) of blood glucose (% or mmol/l)) [ Time Frame: within 4 hours after injection ]
    time dependent decrease (time Δ from injection in min) of blood glucose (% or mmol/l)) that can best discriminate from placebo injection

  2. time to symptoms [ Time Frame: within 4 hours after injection ]
    time to symptoms of the exenatide test in comparison to the placebo injection of 10ml 0.9% saline solution

  3. time to hypoglycemia (time to reach blood sugar level ≤ 2.5 mmol/l) in the exenatide test in comparison to the placebo [ Time Frame: within 4 hours after injection ]
    time to hypoglycemia (time to reach blood sugar level ≤ 2.5 mmol/l) in the exenatide test in comparison to the placebo

  4. time to hypoglycemia (time to reach blood sugar level ≤ 2.5 mmol/l) in the exenatide test in comparison to the fasting test [ Time Frame: within 4 hours after injection ]
    time to hypoglycemia (time to reach blood sugar level ≤ 2.5 mmol/l) in the exenatide test in comparison to the fasting test

  5. time to symptoms in the exenatide test in comparison to the fasting test [ Time Frame: within 4 hours after injection ]
    time to symptoms in the exenatide test in comparison to the fasting test

  6. change in levels of plasma glucose compared to placebo compared to placebo [ Time Frame: within 4 hours after injection ]
    change in levels of plasma glucose compared to placebo

  7. change in levels of insulin compared to placebo [ Time Frame: within 4 hours after injection ]
    change in levels of insulin compared to placebo

  8. change in levels of C-peptide compared to placebo [ Time Frame: within 4 hours after injection ]
    change in levels of C-peptide compared to placebo compared to placebo

  9. change in levels of proinsulin compared to placebo [ Time Frame: within 4 hours after injection ]
    change in levels of proinsulin compared to placebo

  10. change in levels of ß-hydroxybutyrate compared to placebo [ Time Frame: within 4 hours after injection ]
    change in levels of ß-hydroxybutyrate compared to placebo

  11. costs of exenatide test setting (CHF) [ Time Frame: within 4 hours after injection ]
    Comparison of costs of exenatide test setting with fasting test setting



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).).

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04909333


Contacts
Layout table for location contacts
Contact: Kwadwo Antwi, Dr. med. +41 61 32 86684 Kwadwo.Antwi@usb.ch

Locations
Layout table for location information
Switzerland
University Hospital Basel, Division of Nuclear Medicine Recruiting
Basel, Switzerland, 4031
Contact: Kwadwo Antwi, Dr. med.    +41 61 32 86684    Kwadwo.Antwi@usb.ch   
Principal Investigator: Kwadwo Antwi, Dr. med.         
Sub-Investigator: Matthias Hepprich, Dr. med.         
Sub-Investigator: Damian Wild, Prof. Dr. med.         
Sub-Investigator: Felix Kaul, Dr. med.         
Sub-Investigator: Tobias Heye, Dr. med.         
Sub-Investigator: Emanuel Christ, Prof. Dr. med.         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Gottfried und Julia Bangerter-Rhyner-Stiftung
Investigators
Layout table for investigator information
Study Director: Emanuel Christ, Prof. Dr. med. University Hospital of Basel, Interdisciplinary Endocrinology
Layout table for additonal information
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04909333    
Other Study ID Numbers: 2020-00169; qu20Antwi2
First Posted: June 1, 2021    Key Record Dates
Last Update Posted: June 3, 2021
Last Verified: May 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
fasting test
Blood glucose
insulin
proinsulin
C-peptide
betahydroxybutyrate
hypoglycemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Congenital Hyperinsulinism
Hypoglycemia
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pancreatic Diseases
Digestive System Diseases
Infant, Newborn, Diseases
Exenatide
Pharmaceutical Solutions
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists