Imaging the pancreas to understand hypoglycemia after gastric bypass surgery
Visualizing Beta Cells in Patients With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
This study is testing a special imaging technique to see what causes low blood sugar in people who have had gastric bypass surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 2 sites (Arnhem, Gelderland and 1 other locations) |
| Trial ID | NCT03182192 on ClinicalTrials.gov |
What this trial studies
This study investigates hyperinsulinemic hypoglycemia (HH), a rare complication that can occur after Roux-en-Y gastric bypass (RYGB) surgery. By utilizing 68Ga-exendin-4 PET imaging, the researchers aim to differentiate between various underlying causes of HH in patients who have undergone RYGB. The study compares pancreatic imaging results between patients with and without HH to enhance understanding of the condition and optimize treatment strategies. The goal is to identify whether the causes of HH are due to normal beta cell function or an increase in beta cell mass.
Who should consider this trial
Good fit: Ideal candidates include adults who have undergone RYGB at least two years prior and have normal glucose levels.
Not a fit: Patients with a history of diabetes or previous diagnosed hyperinsulinemic hypoglycemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatments for patients experiencing hypoglycemia after gastric bypass surgery.
How similar studies have performed: While there have been studies on hypoglycemia after bariatric surgery, this specific imaging approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Arnhem, Gelderland and 1 other locations
- Rijnstate hospital — Arnhem, Gelderland, Netherlands (Recruiting)
- Radboudumc — Nijmegen, Gelderland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Marti Boss, MSc
- Email: marti.boss@radboudumc.nl
- Phone: +312436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.