DiabetesNCT01621516
Measurement of the Pancreas Function in Patients With More Than One Pancreas After Liver and Small Bowel Transplantation
An observational study of Diabetes and Insulin Resistance, run by KU Leuven.
Trial summary
Under chronic immunosuppressive and corticosteroid therapy, transplant patients have a tendency to develop in the long-term diabetes. Patients who have received extra pancreatic tissue with their liver and small bowel transplantation have not yet developed insulin resistance or diabetes mellitus. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Insulin Resistance, Liver/Small Bowel Transplant
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Nov 2015
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Liver/small bowel transplant patients with partial or whole pancreas (n = 3): Solitary small bowel transplant patients (n=3) * Insuline independen (no diabetes mellitus) * Maintenance IS with Tacrolimus/Azathioprine
Who may be able to join
- Liver/small bowel transplant patients with partial or whole pancreas
- Solitary small bowel transplant patients
- Insulin independent (no diabetes mellitus)
- Maintenance IS with Tacrolimus/Azathioprine
Who cannot join
None listed.
About this study
Official title: Measurement of ß-cell Function and Insulin Sensitivity in Non-diabetic Patients With En-bloc Liver, Pancreas and Small Bowel Transplant Using a Hyperglycemic Clamp
Under chronic immunosuppressive and corticosteroid therapy, transplant patients have a tendency to develop in the long-term diabetes. Patients who have received extra pancreatic tissue with their liver and small bowel transplantation have not yet developed insulin resistance or diabetes mellitus. We would like to investigate to which level insulin secretory capacity the extra pancreas together with the native pancreas has in these transplant patients using the hyperglycemic clamp. These data will be compared with the data obtained from healthy controls.
Read the detailed description
The glycemic control in type 1 diabetic recipients of islet cell grafts is correlated with the ß-cell mass. In the standard technique for liver/small bowel transplant procedure previously described by Grant et al, the pancreas was removed. This surgical method was modified by Sudan et al and the donor pancreas was transplanted intact in these non-diabetic patients. Under chronic immunosuppressive and corticosteroid therapy, these patients with extra ß-cell mass have not developed insulin resistance or diabetes mellitus. To which level insulin secretory capacity the extra pancreas allograft together with the native pancreas has in these transplant patients are not yet known.
Among the measures of pancreatic ß-cell-secretory capacity, the first-phase and steady state insulin secretion from the hyperglycemic clamp studies are believed to give the most robust estimates. Moreover, the hyperglycemic clamp and the euglycemic clamp yield comparable estimates of insulin sensitivity and, so that under appropriate conditions, the hyperglycemic clamp technique may be used to assess both insulin sensitivity and insulin secretion in the same individual in a single experiment.
- Conditions
- Diabetes, Insulin Resistance, Liver/Small Bowel Transplant
- Keywords
- Beta-cell function, Liver/small bowel transplant, Donor pancreas, Diabetes, Long-term immunesuppression
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | 10 healthy volunteers | |
| Solitary small bowel transplant patients | 3 | |
| Liver/small bowel transplant patients | 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the stimulated serum C-peptide leveS (mean area under the curve [AUC] after hypercemic clamp test
- Sampling before glucose infusion (-30 to 0 minutes)
- Glucose infusion (0 to 14 minutes)
- increase of glycemia acutely to 180 mg/dL in approx. 14 min.
- Clamping at glycemia of 180 mg/dL (15 to 150 minutes)
- maintain glycemia at 180 mg/dL till 150 min. after start glucose infusion
- blood sample for measurement of glycemia, proinsulinemia and C-peptide at 120, 135 and 150 minutes (n= 3x5 ml) for evaluation of second-phase insulin release
- Intravenous injection of 1 mg glucagon (150 to 170 minutes)
Measured: One time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionApr 2014
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. Pieter Gillard, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621516
- Sponsor's protocol ID
- BCFTX 001
- Status last verified
- Nov 2015
- First submitted
- 14 Jun 2012
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of ß-cell Function and Insulin Sensitivity in Non-diabetic Patients With En-bloc Liver, Pancreas and Small Bowel Transplant Using a Hyperglycemic Clamp
- ClinicalTrials.gov ID
- NCT01621516
- Acronym / sponsor ID
- BCFTX 001
- Conditions
- Diabetes, Insulin Resistance, Liver/Small Bowel Transplant
- Keywords
- Beta-cell function, Liver/small bowel transplant, Donor pancreas, Diabetes, Long-term immunesuppression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Vrije Universiteit Brussel
- Study start
- Jun 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 18 Jun 2012 (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.
Under chronic immunosuppressive and corticosteroid therapy, transplant patients have a tendency to develop in the long-term diabetes. Patients who have received extra pancreatic tissue with their liver and small bowel transplantation have not yet developed insulin resistance or diabetes mellitus. We would like to investigate to which level insulin secretory capacity the extra pancreas together with the native pancreas has in these transplant patients using the hyperglycemic clamp. These data will be compared with the data obtained from healthy controls.
Detailed description
The glycemic control in type 1 diabetic recipients of islet cell grafts is correlated with the ß-cell mass. In the standard technique for liver/small bowel transplant procedure previously described by Grant et al, the pancreas was removed. This surgical method was modified by Sudan et al and the donor pancreas was transplanted intact in these non-diabetic patients. Under chronic immunosuppressive and corticosteroid therapy, these patients with extra ß-cell mass have not developed insulin resistance or diabetes mellitus. To which level insulin secretory capacity the extra pancreas allograft together with the native pancreas has in these transplant patients are not yet known.
Among the measures of pancreatic ß-cell-secretory capacity, the first-phase and steady state insulin secretion from the hyperglycemic clamp studies are believed to give the most robust estimates. Moreover, the hyperglycemic clamp and the euglycemic clamp yield comparable estimates of insulin sensitivity and, so that under appropriate conditions, the hyperglycemic clamp technique may be used to assess both insulin sensitivity and insulin secretion in the same individual in a single experiment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | –10 healthy volunteers |
| Solitary small bowel transplant patients | – | –3 |
| Liver/small bowel transplant patients | – | –3 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Liver/small bowel transplant patients with partial or whole pancreas (n = 3): Solitary small bowel transplant patients (n=3) * Insuline independen (no diabetes mellitus) * Maintenance IS with Tacrolimus/Azathioprine
Key inclusion criteria (4 listed)
- Liver/small bowel transplant patients with partial or whole pancreas
- Solitary small bowel transplant patients
- Insulin independent (no diabetes mellitus)
- Maintenance IS with Tacrolimus/Azathioprine
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in the stimulated serum C-peptide leveS (mean area under the curve [AUC] after hypercemic clamp test
Time frame: One time
1. Sampling before glucose infusion (-30 to 0 minutes) 2. Glucose infusion (0 to 14 minutes) - increase of glycemia acutely to 180 mg/dL in approx. 14 min. 3. Clamping at glycemia of 180 mg/dL (15 to 150 minutes) * maintain glycemia at 180 mg/dL till 150 min. after start glucose infusion * blood sample for measurement of glycemia, proinsulinemia and C-peptide at 120, 135 and 150 minutes (n= 3x5 ml) for evaluation of second-phase insulin release 4. Intravenous injection of 1 mg glucagon (150 to 170 minutes)
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 11 Nov 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Insulin Resistance, run by KU Leuven.
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 4 inclusion and 0 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 11 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in the stimulated serum C-peptide leveS (mean area under the curve [AUC] after hypercemic clamp test (time frame: One time). 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 11 Nov 2015.