GLP1R-imaging in Post-RYGB Hypoglycemia

April 12, 2024 updated by: Laura Deden, Rijnstate Hospital

Visualizing Beta Cells in Patients With Hyperinsulinemic Hypoglycemia After Bariatric Surgery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pancreatic uptake of 68Ga-NODAGA-exendin-4
Time Frame: baseline
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beta cell function
Time Frame: baseline
Measured as total insulin during MTT and insulin peak during arginine test
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

October 5, 2020

First Submitted That Met QC Criteria

October 27, 2022

First Posted (Actual)

October 28, 2022

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL51854.091.15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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