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GLP1R-imaging in Hypoglycemia

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ClinicalTrials.gov Identifier: NCT03182192
Recruitment Status : Unknown
Verified May 2017 by Radboud University.
Recruitment status was:  Recruiting
First Posted : June 9, 2017
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Rijnstate Hospital
Information provided by (Responsible Party):
Radboud University

Brief Summary:
Hyperinsulinemic hypoglycemia (HH) is a rare complication that occurs 1 to 5 years after gastric bypass surgery. The underlying mechanism of this complication is not yet completely understood. Changes in hormone levels, such as GLP1 after RYGB, nesidioblastosis or an increase in the number of beta cells may be one of the underlying causes. However, several study results are conflicting and it is hypothesized that the patient population with HH after RYGB is heterogeneous and several underlying causes may be present. In order to differentiate between hyperfunction with normal beta cell mass and a general or localized increase in beta cell mass we aim to compare quantitative 68Ga-exendin-4 PET imaging of the pancreas between patients with and without HH after RYGB. Thereby, investigators aim to increase the insight in the underlying mechanism of HH after RYGB. If different underlying causes can be diagnosed, treatment for HH can be optimized for patients.

Condition or disease Intervention/treatment Phase
Hypoglycemia Radiation: 68Ga-NODAGA-exendin-4 PET/CT Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparison of patients with hypoglycemia to control patients
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Visualizing Beta Cells in Patients With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
Actual Study Start Date : April 1, 2016
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
Drug Information available for: Exenatide

Arm Intervention/treatment
Experimental: Hypoglycemia
Patients with hypoglycemia after gastric bypass
Radiation: 68Ga-NODAGA-exendin-4 PET/CT
68Ga-NODAGA-exendin-4 PET/CT scan

Active Comparator: Control
Patients without hypoglycemia after gastric bypass
Radiation: 68Ga-NODAGA-exendin-4 PET/CT
68Ga-NODAGA-exendin-4 PET/CT scan




Primary Outcome Measures :
  1. Uptake of 68Ga-exendin in the pancreas of patients [ Time Frame: 1 year ]
    Calculating uptake by quantitative image analysis


Secondary Outcome Measures :
  1. Correlation of tracer uptake with C-peptide and HbA1c [ Time Frame: 1 year ]
    Correlate tracer uptake with C-peptide and HbA1c in patients



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All individuals:

  • Signed informed consent
  • > 18

Additional for matched control group:

  • RYGB at least 2 years ago
  • Normal glucose levels before and after RYGB
  • Score <7 on Sigstad's scoring system
  • Individual matched to HH group on age

Exclusion Criteria:

All individuals:

  • Anti-diabetic medication in the past 6 months
  • Treatment with synthetic exendin in the past 6 months
  • Liver failure
  • Pregnancy
  • Breast feeding
  • Kidney failure
  • Age < 18
  • No signed informed consent

Additional for matched control group:

  • Any diabetic history
  • Previous diagnosed HH
  • Sigstad's dumping score >7

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): NCT03182192


Contacts
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Contact: Marti Boss, MSc +312436 ext 67243 marti.boss@radboudumc.nl
Contact: Martin Gotthardt, Prof. +312436 ext 55229 martin.gotthardt@radboudumc.nl

Locations
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Netherlands
Rijnstate hospital Recruiting
Arnhem, Gelderland, Netherlands
Contact: Laura Deden, Msc       l.deden@rijnstate.nl   
Radboudumc Recruiting
Nijmegen, Gelderland, Netherlands, 6500HB
Contact: Marti Boss, Msc    +312436 ext 67243    marti.boss@radboudumc.nl   
Sponsors and Collaborators
Radboud University
Rijnstate Hospital

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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03182192     History of Changes
Other Study ID Numbers: NL51854.091.15
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University:
Betal cells
Roux- and Y gastic bypass
exendin
GLP1
Additional relevant MeSH terms:
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Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists