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

Recruiting

• Conditions: Type 2 Diabetes; 10018424; 10017998

• Registration Number: NL-OMON42279
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• 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 (HbA1c in normal range, fasting glucose <100 mg/dl for at least 1 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)

Exclusion Criteria

- Previous treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors
- Breast feeding
- Pregnancy or the wish to become pregnant within 6 months
- Calculated creatinine clearance below 40ml/min
- Age < 18 years
- No signed informed consent

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main parameter of the study is the quantitative assessment of pancreatic<br /><br>68Ga-NODAGA-exendin-4 uptake in responders and non-responders after RYGB by<br /><br>PET/CT. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoint is to the correlation between 68Ga-exendin tracer<br /><br>accumulation and beta cell function of the patients.</p><br>