Type 1 DiabetesGLP-1-CPOPNCT01825148
GLP-1 Receptor Targeting in Diabetic and Healthy Individuals
An observational study of Type 1 Diabetes, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of the study is to determine whether there are differences in pancreatic uptake of the radiotracer between healthy individuals and patients with type 1 diabetes. If T1D patients have a markedly reduced uptake, the compound may be suitable for estimation of pancreatic beta cell mass, i.e. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- radiolabeled Exendin
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2012to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Type 1 Diabetes patients and healthy volunteers responding to advertisment
Who may be able to join
- type 1 Diabetes
Who cannot join
- breast feeding
- pregnant
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, 6500 HB
About this study
Official title: Clinical Proof-of-principle of the Determination of the Beta Cell Mass in Vivo by SPECT Imaging With the 111-In-labeled GLP-1 Analogue DTPA(Diethylenetriamine Pentaacetic Acid)-[K40]-Exendin 4
The purpose of the study is to determine whether there are differences in pancreatic uptake of the radiotracer between healthy individuals and patients with type 1 diabetes. If T1D patients have a markedly reduced uptake, the compound may be suitable for estimation of pancreatic beta cell mass, i.e. the cells in the pancreas that produce insulin.
- Conditions
- Type 1 Diabetes
- Being tested
- radiolabeled Exendin
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiolabeled ExendinOther
| Study group | Role | What they receive |
|---|---|---|
| Type 1 Diabetes | patients with long standing T1D Receives: Other: radiolabeled Exendin | |
| Healthy volunteer | healthy volunteers with normal glucose tolerance Receives: Other: radiolabeled Exendin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pancreatic uptake of radiolabeled Exendin
uptake will be given as counts per MBq injected activity as determined by calibrated SPECT/CT scanner with attenuation correction.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startDec 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Gotthardt, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825148
- Sponsor's protocol ID
- RUNMC-EX-BCM-2012
- Other IDs
- 2012-000619-10
- Acronym
- GLP-1-CPOP
- Status last verified
- Nov 2014
- First submitted
- 18 Mar 2013
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brom M, Woliner-van der Weg W, Joosten L, Frielink C, Bouckenooghe T, Rijken P, Andralojc K, Goke BJ, de Jong M, Eizirik DL, Behe M, Lahoutte T, Oyen WJ, Tack CJ, Janssen M, Boerman OC, Gotthardt M. Non-invasive quantification of the beta cell mass by SPECT with (1)(1)(1)In-labelled exendin. Diabetologia. 2014 May;57(5):950-9. doi: 10.1007/s00125-014-3166-3. Epub 2014 Feb 1.
PubMed 24488022
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Proof-of-principle of the Determination of the Beta Cell Mass in Vivo by SPECT Imaging With the 111-In-labeled GLP-1 Analogue DTPA(Diethylenetriamine Pentaacetic Acid)-[K40]-Exendin 4
- ClinicalTrials.gov ID
- NCT01825148
- Acronym / sponsor ID
- GLP-1-CPOP / RUNMC-EX-BCM-2012
- Conditions
- Type 1 Diabetes
- Keywords
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether there are differences in pancreatic uptake of the radiotracer between healthy individuals and patients with type 1 diabetes. If T1D patients have a markedly reduced uptake, the compound may be suitable for estimation of pancreatic beta cell mass, i.e. the cells in the pancreas that produce insulin.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 1 Diabetes | – | Other: radiolabeled Exendinpatients with long standing T1D |
| Healthy volunteer | – | Other: radiolabeled Exendinhealthy volunteers with normal glucose tolerance |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Type 1 Diabetes patients and healthy volunteers responding to advertisment
Key inclusion criteria (1 listed)
- type 1 Diabetes
Key exclusion criteria (2 listed)
- breast feeding
- pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiolabeled Exendin | Other | Healthy volunteer, Type 1 Diabetes |
Primary outcome
pancreatic uptake of radiolabeled Exendin
Time frame: 7 days
uptake will be given as counts per MBq injected activity as determined by calibrated SPECT/CT scanner with attenuation correction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Derived from this study: PubMed 24488022Brom M, Woliner-van der Weg W, Joosten L, Frielink C, Bouckenooghe T, Rijken P, Andralojc K, Goke BJ, de Jong M, Eizirik DL, Behe M, Lahoutte T, Oyen WJ, Tack CJ, Janssen M, Boerman OC, Gotthardt M. Non-invasive quantification of the beta cell mass by SPECT with (1)(1)(1)In-labelled exendin. Diabetologia. 2014 May;57(5):950-9. doi: 10.1007/s00125-014-3166-3. Epub 2014 Feb 1.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pancreatic uptake of radiolabeled Exendin (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01825148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.