Imaging pancreatic beta cells in patients with post-gastric bypass hypoglycemia
Visualizing Beta Cells in Patients With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
This study is testing how the amount of insulin-producing cells in the pancreas differs between people who have low blood sugar after gastric bypass surgery and those who don’t, to help improve treatment for those affected.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rijnstate Hospital Academic / other |
| Locations | 1 site (Arnhem) |
| Trial ID | NCT05597475 on ClinicalTrials.gov |
What this trial studies
This study evaluates the differences in beta cell mass between patients experiencing hyperinsulinemic hypoglycemia and those without after Roux en Y gastric bypass (RYGB). Using GLP-1R PET imaging, the researchers aim to quantify pancreatic beta cell mass in these groups. The findings could shed light on the mechanisms behind hypoglycemia following bariatric surgery, potentially leading to better management strategies for affected patients.
Who should consider this trial
Good fit: Ideal candidates include individuals who have persistent hyperinsulinemic hypoglycemia after a low-carbohydrate diet or insulin suppressive medication for one year.
Not a fit: Patients who have been on anti-diabetic medication in the past six months or have known liver failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding and treatment of hypoglycemia in patients who have undergone gastric bypass surgery.
How similar studies have performed: While this approach is innovative, there is limited information on the success of similar studies, indicating that this may be a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent Patients: - Persisting hyperinsulinemic hypoglycemia after a low-carbohydrate diet and/or insulin suppressive medication for one year. Controls: * RYGB at least 2 years ago * Normal glucose levels before and after RYGB (fasting glucose between 4 and 6 mmol/l or HbA1c between 20 and 42 mmol/mol) * Score ≤ 7 on Sigstad's scoring system (Table 1) * Hypoglycemia excluded by 14-day continuous glucose monitoring * Individual matched to HH group on age (± 5 years), sex and BMI at time of inclusion (± 2 kg/m2) Exclusion Criteria: * Anti-diabetic medication in the past 6 months * Treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors in the past six months. * Known liver failure or serum liver values over 2 times normal value at the time of standard laboratory assessment. Normal values of total bilirubin, γ-GT, ASAT and albumin are \<21 μmol, \<40 U/l, \<30 U/l and 35-50 g/l respectively * Pregnancy or the wish to become pregnant within 6 months * Breast feeding * Kidney failure, i.e. calculated creatinine clearance below 40 ml/min * Age \< 18 years * No signed informed consent
Where this trial is running
Arnhem
- Rijnstate hospital — Arnhem, Netherlands (Recruiting)
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.