GLP1R-imaging in Post-RYGB Hypoglycemia

Not Applicable

Recruiting

• Conditions: Obesity; Hypoglycemia Post Gastric Bypass Surgery; Hyperinsulinemic Hypoglycemia
• Interventions: Diagnostic Test: GLP-1R PET

• Registration Number: NCT05597475
• Lead Sponsor: Rijnstate Hospital

Brief Summary

In order to evaluate the difference in beta cell mass in patients with and without hyperinsulinemic hypoglycemia after Roux en Y gastric bypass (RYGB) investigators aim to compare quantitative PET imaging of the pancreas between these patient groups.

These highly relevant data will provide investigators with more information on the possible role of beta cell mass in the mechanisms of hyperinsulinemic hypoglycemia bariatric surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-01
• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2022-10-27
• Study First Posted: 2022-10-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-15
• Primary Completion: 2024-05-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	GLP-1R PET	Patients with hypoglycemia
Controls	GLP-1R PET	Patients without post-bariatric hypoglycemia

Primary Outcome Measures

Name	Time	Method
Pancreatic uptake of 68Ga-NODAGA-exendin-4	baseline

Secondary Outcome Measures

Name	Time	Method
Beta cell function	baseline	Measured as total insulin during MTT and insulin peak during arginine test

Trial Locations

Locations (1)

Rijnstate hospital; 🇳🇱 Arnhem, Netherlands