Visualizing Beta Cells in Patients With Hyperinsulinemic Hypoglycemia After Bariatric Surgery

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
Netherlands
Rijnstate hospital
RECRUITING
Arnhem
Radboudumc
RECRUITING
Nijmegen
Contact Information
Primary
Marti Boss, MSc
marti.boss@radboudumc.nl
+312436
Backup
Martin Gotthardt, Prof.
martin.gotthardt@radboudumc.nl
+312436
Time Frame
Start Date: 2016-04-01
Estimated Completion Date: 2024-07-01
Participants
Target number of participants: 12
Treatments
Experimental: Hypoglycemia
Patients with hypoglycemia after gastric bypass
Active_comparator: Control
Patients without hypoglycemia after gastric bypass
Sponsors
Leads: Radboud University Medical Center
Collaborators: Rijnstate Hospital

This content was sourced from clinicaltrials.gov

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