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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05597475
Other study ID # NL51854.091.15
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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