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

Phase 1

Conditions: Diabetes Type 2, bariatric surgery, morbid obesitas
MedDRA version: 19.0Level: HLGTClassification code 10018424Term: Glucose metabolism disorders (incl diabetes mellitus)System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 19.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 19.0Level: HLTClassification code 10012602Term: Diabetes mellitus (incl subtypes)System Organ Class: 10014698 - Endocrine disorders
Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Registration Number: EUCTR2014-005599-27-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: Female

Target Recruitment: 12

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 < 2 years before RYGB
o Only metformin usage as anti-diabetic medication

Severe T2D group
o C-peptide < 1 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

- Fasting glucose < 7 mmol/l at time C-peptide was determined (Aarts et al. 2013)
- Known liver failure or serum liver values over 2 times normal value at the time of standard laboratory assessment.
- BMI > 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