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.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameter of the study is the quantitative assessment of pancreatic
68Ga-NODAGA-exendin-4 uptake in responders and non-responders after RYGB by
PET/CT.
Secondary outcome
The secondary endpoint is to the correlation between 68Ga-exendin tracer
accumulation and beta cell function of the patients.
Background summary
In order to evaluate the difference in beta cell mass in patients with and
without complete resolution of type 2 diabetes mellitus (T2DM) after Roux en Y
gastric bypass (RYGB) we aim to compare quantitative PET imaging of the
pancreas between these patient groups.
Study 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.
Study design
Dual center phase 1 study we will assess the difference in beta cell mass
between obese T2D patients with or without complete resolution of T2D after
bariatric surgery by quantitative analysis of 68Ga-NODAGA-exendin-4 PET/CT
images.
Study burden and risks
Injection of the radiopharmaceutical may theoretically result in nausea and
headache as has been reported for (much higher doses) of Byetta® in therapy
studies. In addition, single cases of low blood pressure and low blood glucose
levels have been described. Although low blood glucose levels only occurred
after accidental heavy overdosing of Byetta®, patients will be closely
monitored. However, in a previous study (CPOP-EX), we did not observe any side
or adverse effects after 111In-DTPA-[K40]-Exendin 4 injection for all 20
patients included.
The expected radiation exposure will not exceed 5 mSv and is therefore
considered minimal to little. However, if the technique would indeed allow
sensitive and specific visualization and quantification of beta cell mass in
patients after RYGB, the impact on evaluation of bariatric surgery as an
alternative therapy for T2DM would be very high.
Geert Grooteplein-Zuid 10
Nijmegen 6500 HB
NL
Geert Grooteplein-Zuid 10
Nijmegen 6500 HB
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-004317-90-NL |
| CCMO | NL51058.091.14 |