This study has been transitioned to CTIS with ID 2024-520392-27-00 check the CTIS register for the current data. The primary objective is to evaluate the difference in 68Ga-exendin tracer accumulation in the pancreas of women with and without a…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the difference between the uptake of
68Ga-NODAGA-exendin-4 (measured by quantification/quantitative analysis of PET
images) in the pancreas of women with and without a history of gestational
diabetes mellitus as a measure for beta cell mass.
Secondary outcome
The secondary endpoint is to the correlation between 68Ga-exendin tracer
accumulation and beta cell function of the subjects.
Background summary
In order to evaluate the difference in beta cell mass in women with and without
a history of gestational diabetes mellitus (GDM) we aim to compare quantitative
PET imaging of the pancreas between these groups.
Study objective
This study has been transitioned to CTIS with ID 2024-520392-27-00 check the CTIS register for the current data.
The primary objective is to evaluate the difference in 68Ga-exendin tracer
accumulation in the pancreas of women with and without a history of GDM by
quantitative analysis of PET images.
Study design
Women with a history of GDM and women without a history of GDM as a control
group will be recruited at the Radboudumc and by advertisement. After
recruitment of the participating individuals, all women will undergo an
enrolment check at the Department of Radiology and Nuclear Medicine at the
Radboudumc consisting of a medical interview and a physical examination
performed by a qualified physician. Blood samples will be taken for laboratory
checks (glucose, HbA1c, C-peptide, creatinine, ALAT, ASAT). On the same day an
oral glucose tolerance test will be performed.
At the second visit, a PET/CT scan will be performed at the Radboudumc.
68Ga-NODAGA-exendin-4 will be administered to all participants. 1 hour after
injection a PET/CT scan will be performed.
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, although this has not been observed in imaging studies so far. In
addition, single cases of low blood pressure and low blood glucose levels have
been described after application of therapeutic or higher doses of Byetta®.
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. Furthermore,
in a study of Christ et al. no side effects were observed in 30 patients with
endogenous hyperinsulinemic hypoglycemia after injection of
111In-DTPA-exendin-4. The expected radiation exposure will not exceed 5 mSv and
is therefore considered minimal to little. However, sensitive and specific
visualization and quantification of beta cell mass with this technique would be
highly relevant for further understanding of the pathophysiology of type 2
diabetes and the development of new treatment options.
Geert Grooteplein-Zuid 10
Nijmegen 6500 HB
NL
Geert Grooteplein-Zuid 10
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria (women with history of GDM);- Pregnancy with diagnosis of GDM, within the last 5 years;- No other previous pregnancies;- Complete resolution of GDM after delivery (HbA1c in normal range, fasting glucose < 100 mg/dl for at least 1 year in the absence of active pharmacologic therapy or ongoing procedures);- Signed informed consent;Inclusion criteria (women without history of GDM);- Pregnancy without problems in glucose homeostasis, within the last 5 years;- No other previous pregnancies;- No evidence of T2D at time of inclusion (HbA1c in normal range, fasting glucose < 100 mg/dl for at least 1 year in the absence of active pharmacologic therapy);- Insulin secretion-sensitivity index-2 (ISSI-2) >= 800 on oral glucose tolerance test;- Signed informed consent
Exclusion criteria
Exclusion criteria;- Previous treatment (within 6 months) with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors;- Breast feeding;- Current pregnancy or the wish to become pregnant within 6 months;- Renal dysfunction (Calculated creatinine clearance below 40ml/min);- Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range ;- Age < 18 years;- Incapacitated;- No signed informed consent
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-520392-27-00 |
| EudraCT | EUCTR2016-000794-20-NL |
| CCMO | NL56938.091.16 |