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GLP1R-imaging in Hypoglycemia

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. Identifier: NCT03182192
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : October 10, 2019
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

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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, 2021
Estimated Study Completion Date : February 1, 2021

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

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.

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

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 identifier (NCT number): NCT03182192

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Contact: Marti Boss, MSc +312436 ext 67243
Contact: Martin Gotthardt, Prof. +312436 ext 55229

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Rijnstate hospital Recruiting
Arnhem, Gelderland, Netherlands
Contact: Laura Deden, Msc   
Radboudumc Recruiting
Nijmegen, Gelderland, Netherlands, 6500HB
Contact: Marti Boss, Msc    +312436 ext 67243   
Sponsors and Collaborators
Radboud University
Rijnstate Hospital

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Responsible Party: Radboud University Identifier: NCT03182192    
Other Study ID Numbers: NL51854.091.15
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
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
Additional relevant MeSH terms:
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Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Hormones, Hormone Substitutes, and Hormone Antagonists