GLP1R-imaging in Post-RYGB Hypoglycemia

NCT05597475 | Recruiting

• 1 other identifier: NL51854.091.15
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Hypoglycemia Post Gastric Bypass Surgery; Hyperinsulinemic Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Pancreatic uptake of 68Ga-NODAGA-exendin-4

  baseline

Secondary Outcomes (1)

• Beta cell function

  baseline

Study Arms (2)

Patients

OTHER

Patients with hypoglycemia

Diagnostic Test: GLP-1R PET

Controls

OTHER

Patients without post-bariatric hypoglycemia

Diagnostic Test: GLP-1R PET

Interventions

GLP-1R PET DIAGNOSTIC_TEST

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

Also known as: Meal tolerance test, Arginine stimulation test

Controls; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Rijnstate hospital

Arnhem, Netherlands

RECRUITING

MeSH Terms

Conditions

Obesity; Congenital Hyperinsulinism

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 28, 2022
• Study Start: November 1, 2016
• Primary Completion: May 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

NL (1)