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RecruitingNCT05597475Updated Apr 15, 2024

GLP1R-imaging in Post-RYGB Hypoglycemia

An interventional study of GLP-1R PET in Obesity, Hypoglycemia Post Gastric Bypass Surgery and Hyperinsulinemic Hypoglycemia, sponsored by Rijnstate Hospital. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-15.

Sponsored by Rijnstate Hospital · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity
  • Hypoglycemia Post Gastric Bypass Surgery
  • Hyperinsulinemic Hypoglycemia
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Other
    Patients

    Patients with hypoglycemia

    Diagnostic Test: GLP-1R PET

  • Other
    Controls

    Patients without post-bariatric hypoglycemia

    Diagnostic Test: GLP-1R PET

Interventions

  • Diagnostic testGLP-1R PET

    Beta cell function (tests) and measure for beta cell mass (PET)

    Also known as: Meal tolerance test, Arginine stimulation test

05

What researchers measure

Primary outcomes

  1. Pancreatic uptake of 68Ga-NODAGA-exendin-4

    Time frame: baseline

Secondary outcomes

  1. Beta cell function

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

    Time frame: baseline

06

Study locations

1 of 1 sites recruiting
  • Rijnstate hospital
    Arnhem, Netherlands
    Recruiting
07

Registry details

Key details

Study ID
NCT05597475
Lead sponsor
Rijnstate Hospital
Responsible party
Laura Deden (Principal Investigator, Rijnstate Hospital) — Principal investigator
First posted
Oct 28, 2022
Start date
Nov 1, 2016
Primary completion
May 30, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Apr 15, 2024
View the source record on ClinicalTrials.gov ↗

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