GLP1R-imaging in Hypoglycemia
Visualizing Beta Cells in Patients With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
1 other identifier
interventional
12
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2016
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 29, 2017
CompletedFirst Posted
Study publicly available on registry
June 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedDecember 8, 2023
November 1, 2023
8.3 years
May 29, 2017
December 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Uptake of 68Ga-exendin in the pancreas of patients
Calculating uptake by quantitative image analysis
1 year
Secondary Outcomes (1)
Correlation of tracer uptake with C-peptide and HbA1c
1 year
Study Arms (2)
Hypoglycemia
EXPERIMENTALPatients with hypoglycemia after gastric bypass
Control
ACTIVE COMPARATORPatients without hypoglycemia after gastric bypass
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- Rijnstate Hospitalcollaborator
Study Sites (2)
Rijnstate hospital
Arnhem, Gelderland, Netherlands
Radboudumc
Nijmegen, Gelderland, 6500HB, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2017
First Posted
June 9, 2017
Study Start
April 1, 2016
Primary Completion
July 1, 2024
Study Completion
July 1, 2024
Last Updated
December 8, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share