Back to resultsGLP1R-imaging in Post-RYGB Hypoglycemia
Primary Purpose
Obesity, Hypoglycemia Post Gastric Bypass Surgery, Hyperinsulinemic Hypoglycemia
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
GLP-1R PET
Sponsored by
About this trial
This is an interventional basic science trial for Obesity
Eligibility Criteria
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
Sites / Locations
- Rijnstate hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patients
Controls
Arm Description
Patients with hypoglycemia
Patients without post-bariatric hypoglycemia
Outcomes
Primary Outcome Measures
Pancreatic uptake of 68Ga-NODAGA-exendin-4
Secondary Outcome Measures
Beta cell function
Measured as total insulin during MTT and insulin peak during arginine test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05597475
Brief Title
GLP1R-imaging in Post-RYGB Hypoglycemia
Official Title
Visualizing Beta Cells in Patients With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
January 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rijnstate Hospital
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Hypoglycemia Post Gastric Bypass Surgery, Hyperinsulinemic Hypoglycemia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Other
Arm Description
Patients with hypoglycemia
Arm Title
Controls
Arm Type
Other
Arm Description
Patients without post-bariatric hypoglycemia
Intervention Type
Diagnostic Test
Intervention Name(s)
GLP-1R PET
Other Intervention Name(s)
Meal tolerance test, Arginine stimulation test
Intervention Description
Beta cell function (tests) and measure for beta cell mass (PET)
Primary Outcome Measure Information:
Title
Pancreatic uptake of 68Ga-NODAGA-exendin-4
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Beta cell function
Description
Measured as total insulin during MTT and insulin peak during arginine test
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Rijnstate hospital
City
Arnhem
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Deden, MSc
Phone
+31880058888
Email
ldeden@rijnstate.nl
12. IPD Sharing Statement
Learn more about this trial
GLP1R-imaging in Post-RYGB Hypoglycemia
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