GLP1R-imaging in Post-RYGB Hypoglycemia

Obesity Clinical Trial

Official title:

Visualizing Beta Cells in Patients With Hyperinsulinemic Hypoglycemia After Bariatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05597475
• Other study ID #: NL51854.091.15
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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, ?-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

Related Conditions & MeSH terms

• Congenital Hyperinsulinism
• Hyperinsulinemic Hypoglycemia
• Hypoglycemia
• Nesidioblastosis
• Obesity

Intervention

Diagnostic Test:
• GLP-1R PET
Beta cell function (tests) and measure for beta cell mass (PET)

Locations

Country	Name	City	State
Netherlands	Rijnstate hospital	Arnhem

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pancreatic uptake of 68Ga-NODAGA-exendin-4		baseline
Secondary	Beta cell function	Measured as total insulin during MTT and insulin peak during arginine test	baseline