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Clinical Trials/EUCTR2014-005599-27-NL
EUCTR2014-005599-27-NL
Active, not recruiting
Phase 1

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

Radboud University Medical Center Nijmegen0 sites12 target enrollmentSeptember 28, 2016
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DrugsByetta

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Radboud University Medical Center Nijmegen
Enrollment
12
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 28, 2016
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Radboud University Medical Center Nijmegen

Eligibility Criteria

Inclusion Criteria

  • •\- Morbid obese T2D patient who will undergone RYGB at the Rijnstate in Arnhem (BMI \> 35 kg/m2\)
  • •\- 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

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

Outcomes

Primary Outcomes

Not specified

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