Kidney TransplantationNCT00618761
Insulin Secretory Capacity in Insulin-independent Pancreas-Kidney Recipients Compared to Controls
A study testing hyperglycemic clamp test in people with Kidney Transplantation and Pancreas Transplantation, run by University Hospital, Gasthuisberg at 1 site in Belgium.
Trial summary
The purpose of this study is to compare functional beta-cell mass using the hyperglycaemic clamp test in insulin-independent pancreas-kidney recipients with that in non-diabetic kidney recipients and normal controls as well as with the partially previously reported data in beta-cell recipients. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Transplantation, Pancreas Transplantation
- What is being tested?
- hyperglycemic clamp test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2004to Jan 2014
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- kidney pancreas recipients
- kidney recipients
- healthy volunteers
- beta-cell recipients
- immunosuppression with MMF-Tacrolimus
- 1-4 years after transplantation
Who cannot join
- high doses of steroids
- insulin dependent
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Department of Endocrinology, Leuven, UZ-Gasthuisberg
Leuven, 3000
Pieter Gillard, M.D., 003216346994, pieter.gillard@uz.kuleuven.ac.be
Pieter Gillard, M.D.
About this study
Official title: Insulin Secretory Capacity in Insulin-independent Pancreas-Kidney Recipients Compared to Non-Diabetic Kidney Recipients, Insulin Independent Recipients of Beta-cell Grafts and Healthy Controls.
The purpose of this study is to compare functional beta-cell mass using the hyperglycaemic clamp test in insulin-independent pancreas-kidney recipients with that in non-diabetic kidney recipients and normal controls as well as with the partially previously reported data in beta-cell recipients.
- Conditions
- Kidney Transplantation, Pancreas Transplantation
- Being tested
- hyperglycemic clamp test
- Keywords
- glucose clamp, beta-cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperglycemic clamp testOther
hyperglycemic clamp test
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | kidney-pancreas recipients Receives: Other: hyperglycemic clamp test |
| 2 | Active comparator | kidney recipients Receives: Other: hyperglycemic clamp test |
| 3 | Active comparator | healthy controls Receives: Other: hyperglycemic clamp test |
| 4 | Active comparator | beta-cell recipients Receives: Other: hyperglycemic clamp test |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin secretion during clamp test
Measured: time 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startOct 2004
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Fund for Scientific Research, Flanders, Belgium
- Responsible party
- Principal investigator, Pieter Gillard, University Hospital, Gasthuisberg
- Investigators
- Chantal Mathieu, M.D., PhD, Principal investigator, UZ-Gasthuisberg, Department of Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618761
- Sponsor's protocol ID
- clamp01
- Other IDs
- JDRF 4/2005/1327
- Status last verified
- Jan 2008
- First submitted
- 6 Feb 2008
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Secretory Capacity in Insulin-independent Pancreas-Kidney Recipients Compared to Non-Diabetic Kidney Recipients, Insulin Independent Recipients of Beta-cell Grafts and Healthy Controls.
- ClinicalTrials.gov ID
- NCT00618761
- Acronym / sponsor ID
- clamp01
- Conditions
- Kidney Transplantation, Pancreas Transplantation
- Keywords
- glucose clamp, beta-cell
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Fund for Scientific Research, Flanders, Belgium
- Study start
- Oct 2004
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 20 Feb 2008 (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 this study is to compare functional beta-cell mass using the hyperglycaemic clamp test in insulin-independent pancreas-kidney recipients with that in non-diabetic kidney recipients and normal controls as well as with the partially previously reported data in beta-cell recipients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: hyperglycemic clamp testkidney-pancreas recipients |
| 2 | Active comparator | Other: hyperglycemic clamp testkidney recipients |
| 3 | Active comparator | Other: hyperglycemic clamp testhealthy controls |
| 4 | Active comparator | Other: hyperglycemic clamp testbeta-cell recipients |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- kidney pancreas recipients
- kidney recipients
- healthy volunteers
- beta-cell recipients
- immunosuppression with MMF-Tacrolimus
Key exclusion criteria (2 listed)
- high doses of steroids
- insulin dependent
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 |
|---|---|---|
| hyperglycemic clamp testhyperglycemic clamp test | Other | 1, 2, 3, 4 |
Primary outcome
insulin secretion during clamp test
Time frame: time 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2012.
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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.
Chantal Mathieu, M.D., PhD principal investigator
UZ-Gasthuisberg, Department of Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperglycemic clamp test in people with Kidney Transplantation and Pancreas Transplantation, run by University Hospital, Gasthuisberg at 1 site in Belgium.
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 6 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: status not confirmed, as of the sponsor's last update on 15 Jun 2012. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chantal Mathieu, M.D., PhD. (0032/16/346994, chantal.mathieu@uz.kuleuven.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
insulin secretion during clamp test (time frame: time 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2012.