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

Conditions: Patients with Type 2 Diabetes, with or without remission after bariatric surgery
MedDRA version: 17.1Level: HLGTClassification code 10018424Term: Glucose metabolism disorders (incl diabetes mellitus)System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 17.1Level: HLTClassification code 10012602Term: Diabetes mellitus (incl subtypes)System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 17.1Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Registration Number: EUCTR2014-004317-90-NL

Lead Sponsor: Radboud University Medical Center Nijmegen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 24

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 <100 mg/dl for at least I
year in the absence of active pharmacologic therapy or ongoing procedures)
non-responders:
- Obese T2D patient who has undergone RYGB at least one year earlier
- Signed informed consent
- No complete resolution of T2DM after surgery (still requires treatment with oral hypoglycaemic agents or insulin)
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 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>accumulation and beta cell function of the patients as assessed by oral glucose tolerance<br>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 Outcome Measures

Name	Time	Method
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