Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05597475
Other study ID # NL51854.091.15
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2016
Est. completion date December 30, 2024

Study information

Verified date April 2024
Source Rijnstate Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date December 30, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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, ?-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 Design


Intervention

Diagnostic Test:
GLP-1R PET
Beta cell function (tests) and measure for beta cell mass (PET)

Locations

Country Name City State
Netherlands Rijnstate hospital Arnhem

Sponsors (1)

Lead Sponsor Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pancreatic uptake of 68Ga-NODAGA-exendin-4 baseline
Secondary Beta cell function Measured as total insulin during MTT and insulin peak during arginine test baseline
See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2