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GLP1R-imaging in Post-RYGB Hypoglycemia

Sponsor
Rijnstate Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05597475
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
85.9
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: GLP-1R PET
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Visualizing Beta Cells in Patients With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
Actual Study Start Date :
Nov 1, 2016
Anticipated Primary Completion Date :
Jan 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Patients

Patients with hypoglycemia

Diagnostic Test: GLP-1R PET
Beta cell function (tests) and measure for beta cell mass (PET)
Other Names:
  • Meal tolerance test
  • Arginine stimulation test

    		•
    Other: Controls

    Patients without post-bariatric hypoglycemia

    Diagnostic Test: GLP-1R PET
    Beta cell function (tests) and measure for beta cell mass (PET)
    Other Names:
  • Meal tolerance test
  • Arginine stimulation test

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pancreatic uptake of 68Ga-NODAGA-exendin-4 [baseline]

    Secondary Outcome Measures

    1. Beta cell function [baseline]

      Measured as total insulin during MTT and insulin peak during arginine test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rijnstate hospital Arnhem Netherlands

    Sponsors and Collaborators

    • Rijnstate Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Laura Deden, Principal Investigator, Rijnstate Hospital
    ClinicalTrials.gov Identifier:
    NCT05597475
    Other Study ID Numbers:
    • NL51854.091.15
    First Posted:
    Oct 28, 2022
    Last Update Posted:
    Oct 28, 2022
    Last Verified:
    Oct 1, 2022
    Additional relevant MeSH terms:
    Congenital Hyperinsulinism
    Nesidioblastosis
    Hypoglycemia

    Study Results

    No Results Posted as of Oct 28, 2022