Visualizing beta cells in patients with remission of T2DM after bariatric surgery

Visualizing beta cells in patients with remission of T2DM after bariatric surgery - Visualizing beta cells after bariatric surgery

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004317-90-NL

Enrollment

Registered

2015-01-07

Start date

2015-02-25

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Type 2 Diabetes, with or without remission after bariatric surgery MedDRA version: 17.1 Level: HLGT Classification code 10018424 Term: Glucose metabolism disorders (incl diabetes mellitus) System Organ Class: 10014698 - Endocrine disorders MedDRA version: 17.1 Level: HLT Classification code 10012602 Term: Diabetes mellitus (incl subtypes) System Organ Class: 10014698 - Endocrine disorders MedDRA version: 17.1 Level: PT Classification code 10012601 Term: Diabetes mellitus System

Interventions

Trade Name: Byetta Product Name: 68-Ga-NODAGA-[K40]-Exendin4 Pharmaceutical Form: Radiopharmaceutical precursor, solution

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Responders: - Obese T2D patient who has undergone RYGB at least one year earlier - Signed informed consent - Complete resolution of T2DM after surgery (HbAl c in normal range, fasting glucose =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Previous treatment with synthetic Exendin (Exenatide, Byetta@) or Dipeptidyl-Peptidase lV inhibitors - Breast feeding - Pregnancy or the wish to become pregnant within 6 months - Calculated creatinine clearance below 4Oml/min - Age . 18 years - No signed informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to evaluate the difference in 68Ga-exendin tracer accumulation in the pancreas of patients with and without complete resolution of T2DM after RYGB by quantitative analysis of PET images.;Secondary Objective: The secondary objective is to determine the correlation between 68Ga-exendin tracer accumulation and beta cell function of the patients as assessed by oral glucose tolerance testing and arginine stimulation.;Primary end point(s): The main parameter of the study is the quantitative assessment of pancreatic 68Ga-NODAGA-exendin4 uptake in responders and non-responders after RYGB by PET/CT.;Timepoint(s) of evaluation of this end point: 1 hour after injection of the tracer	—

Measure

Time frame

Main Objective: The primary objective is to evaluate the difference in 68Ga-exendin tracer accumulation in the pancreas of patients with and without complete resolution of T2DM after RYGB by quantitative analysis of PET images.;Secondary Objective: The secondary objective is to determine the correlation between 68Ga-exendin tracer accumulation and beta cell function of the patients as assessed by oral glucose tolerance testing and arginine stimulation.;Primary end point(s): The main parameter of the study is the quantitative assessment of pancreatic 68Ga-NODAGA-exendin4 uptake in responders and non-responders after RYGB by PET/CT.;Timepoint(s) of evaluation of this end point: 1 hour after injection of the tracer

—

Secondary

Measure	Time frame
Secondary end point(s): The secondary endpoint is to the correlation between 68Ga-exendin tracer accumulation and beta cell function of the patients.;Timepoint(s) of evaluation of this end point: 1 hour after injection of the tracer	—

Countries

Netherlands

Contacts

Public ContactDepartment of nuclear medicine

Radboud University Medical Center Nijmegen

marti.boss@radboudumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026