Visualizing beta cells in morbid obese patients with T2D before and after bariatric surgery (NL51980.091.15)

Visualizing beta cells in morbid obese patients with T2D before and after bariatric surgery (NL51980.091.15) - Visualizing beta cells before and after bariatric surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005599-27-NL

Enrollment

Registered

2016-09-28

Start date

2016-12-07

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

Diabetes Type 2, bariatric surgery, morbid obesitas MedDRA version: 19.0 Level: HLGT Classification code 10018424 Term: Glucose metabolism disorders (incl diabetes mellitus) System Organ Class: 10014698 - Endocrine disorders MedDRA version: 19.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 19.0 Level: HLT Classification code 10012602 Term: Diabetes mellitus (incl subtypes) System Organ C

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Morbid obese T2D patient who will undergone RYGB at the Rijnstate in Arnhem (BMI > 35 kg/m2) - Female - Signed informed consent Mild T2D group o C-peptide > 1.3 nmol/l o T2D diagnosis 4 years before RYGB o Insulin and/or sulfonylurea (SU) usage Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Fasting glucose 50 kg/m2 - Previous treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors - Pregnancy or the wish to become pregnant within 18 months - Breast feeding - Kidney failure, i.e. calculated creatinine clearance below 40ml/min - Age < 18 years - No signed informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to examine the change in 68Ga-exendin tracer accumulation in the pancreas (i.e. beta cell mass) after RYGB by quantitative analysis of PET images before and one year after RYGB in morbid obese patients with type 2 diabetes. ;Secondary Objective: Secondary objectives are: - Examine if pre-operative pancreatic 68Ga-exendin accumulation has a prognostic value for T2D resolution in morbid obese patients with T2D. - Determine the correlation between pre- and post-RYGB beta cell function and insulin resistance and 68Ga-exendin tracer accumulation in the pancreas. ;Primary end point(s): The main study parameter is the difference in uptake of 68Ga-NODAGA-exendin-4 in the pancreas one year after a RYGB, measured by quantitative analysis of the PET images before and one year after a RYGB. Secondary endpoint is the correlation between T2D outcome and the change in pancreatic uptake of 68Ga-NODAGA-exendin-4 one year after a RYGB. ;Timepoint(s) of evaluation of this end point: PET scan is performed 1 hour after injection of radiopharmacon	—

Measure

Time frame

Main Objective: The main objective is to examine the change in 68Ga-exendin tracer accumulation in the pancreas (i.e. beta cell mass) after RYGB by quantitative analysis of PET images before and one year after RYGB in morbid obese patients with type 2 diabetes. ;Secondary Objective: Secondary objectives are: - Examine if pre-operative pancreatic 68Ga-exendin accumulation has a prognostic value for T2D resolution in morbid obese patients with T2D. - Determine the correlation between pre- and post-RYGB beta cell function and insulin resistance and 68Ga-exendin tracer accumulation in the pancreas. ;Primary end point(s): The main study parameter is the difference in uptake of 68Ga-NODAGA-exendin-4 in the pancreas one year after a RYGB, measured by quantitative analysis of the PET images before and one year after a RYGB. Secondary endpoint is the correlation between T2D outcome and the change in pancreatic uptake of 68Ga-NODAGA-exendin-4 one year after a RYGB. ;Timepoint(s) of evaluation of this end point: PET scan is performed 1 hour after injection of radiopharmacon

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary parameters are the correlation between pre-operatively measured pancreatic 68Ga-exendin uptake and T2D resolution and the correlation between pancreatic 68Ga-exendin uptake and beta cell function before and after RYGB.;Timepoint(s) of evaluation of this end point: PET scan is performed 1 hour after injection of radiopharmacon	—

Countries

Netherlands

Contacts

Public ContactDepartment surgery

Rijnstate hospital

ldeden@rijnstate.nl

Outcome results

None listed

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