MedTrace Logo

GLP1-imaging Before and After Bariatric Surgery

NCT03182231 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-06-21

No results posted yet for this study

Summary

In order to evaluate the difference in beta cell mass in morbidly obese patients with type 2 diabetes mellitus (T2D) before and after Roux-en-Y gastric bypass (RYGB), investigators aim to compare quantitative PET imaging of the pancreas in this patient group before and after surgery. Investigators propose to measure the uptake of 68Ga-NODAGA-exendin-4 in the pancreatic beta cells of these patients. Furthermore, investigators aim to compare uptake of the radiolabeled tracer to beta cell function measured by laboratory parameters. These highly relevant data will provide investigators with more information on the contribution of the beta cells to the mechanisms behind resolution of T2D after bariatric surgery and on the prognostic value of pre-operative beta cell mass determination to T2D resolution. This might be of great interest for the assessment of RYGB as an alternative therapy in patients with T2D and a BMI \<35, who currently do not meet the international guidelines for bariatric surgery.

Conditions

  • Diabetes Mellitus, Type 2
  • Bariatric Surgery Candidate

Interventions

RADIATION

68Ga-NODAGA-exendin-4 PET/CT

68Ga-NODAGA-exendin-4 PET/CT

Sponsors & Collaborators

  • Rijnstate Hospital

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-07
Primary Completion
2023-07-01
Completion
2023-07-01

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03182231 on ClinicalTrials.gov