Hyperglycaemia (Diabetic)Phase 4INS_LTPLNCT03152890
Insulin Therapy for Postreperfusion Hyperglycemia
A Phase 4 study testing Insulin in people with Hyperglycaemia (Diabetic) and Liver Transplantation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Glycemic control during liver transplantation is challenging especially after reperfusion of the liver graft. Insulin dose to treat postreperfusion hyperglycemia is retrospectively analyzed using historical data. The proposed dose then is prospectively applied to the patients to assess the adequacy of the insulin dose. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hyperglycaemia (Diabetic), Liver Transplantation
- What is being tested?
- Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 May 2017to 31 Dec 2024
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver recipients who showed hyperglycemia (blood glucose >180mg/dL) after reperfusion of liver graft.
Who cannot join
- pediatric patients
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-799
Jeong-Hwa Hong, MD, 82-2-740-8096, jhhong@snu.ac.kr
Chul-Woo Jung, MD. PhD
About this study
Official title: Insulin Therapy for Postreperfusion Hyperglycemia in Liver Transplantation
Glycemic control during liver transplantation is challenging especially after reperfusion of the liver graft. Insulin dose to treat postreperfusion hyperglycemia is retrospectively analyzed using historical data. The proposed dose then is prospectively applied to the patients to assess the adequacy of the insulin dose.
Read the detailed description
Hyperglycemia is common during liver transplantation ,especially after graft reperfusion. Response to insulin is frequently unpredictable during postreperfusion period with no consensus or guidelines on glycemic control. The primary aim of this mixed retrospective/prospective study is to investigate the optimal insulin dose to treat hyperglycemia during the postreperfusion period of liver transplantation.
In the retrospective study, adult liver recipients (>18 years old) who underwent liver transplantation between 2004 and 2016 are reviewed. Delta glucose is the primary outcome variable defined as the difference in blood glucose levels before and after insulin administration. The relationship between the insulin dose and delta glucose is analyzed with a linear mixed effects analysis to find the optimal insulin dose to treat postreperfusion hyperglycemia.
In the prospective trial, the proposed insulin dose is administered to the patient who showed hyperglycemia after graft reperfusion. The frequency and magnitude of glucose reduction is the primary outcome. The secondary outcome is the incidence and degree of hypoglycemia.
- Conditions
- Hyperglycaemia (Diabetic), Liver Transplantation
- Being tested
- Insulin
- Keywords
- Insulin, Liver transplantation, Hyperglycemia
- Medical subject headings
- Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
If blood glucose level after reperfusion of liver graft exceeds 180 mg/dL, the insulin dose proposed by the linear mixed effects analysis is given as a bolus.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | The study group receives a linear mixed effects model-proposed dose of insulin when hyperglycemia is noticed after reperfusion of liver graft. Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of blood glucose level 20 minutes after insulin administration
Insulin is administered immediately after baseline hyperglycemia (blood glucose >180 mg/dL) has been observed.
Change of blood glucose level after insulin administration is calculated as (baseline glucose - glucose after insulin administration).
Measured: 20 minutes after insulin administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start15 May 2017
- Primary completion15 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperglycaemia (Diabetic)Studies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study group receives a linear mixed effects model-proposed dose of insulin when hyperglycemia is noticed after reperfusion of liver graft.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chul-Woo Jung, Seoul National University Hospital
- Investigators
- Chul-Woo Jung, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152890
- Sponsor's protocol ID
- Insulin_LTPL
- Acronym
- INS_LTPL
- Status last verified
- Apr 2024
- First submitted
- 3 May 2017
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Therapy for Postreperfusion Hyperglycemia in Liver Transplantation
- ClinicalTrials.gov ID
- NCT03152890
- Acronym / sponsor ID
- INS_LTPL / Insulin_LTPL
- Conditions
- Hyperglycaemia (Diabetic), Liver Transplantation
- Keywords
- Insulin, Liver transplantation, Hyperglycemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 May 2017 (actual)
- 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.
Glycemic control during liver transplantation is challenging especially after reperfusion of the liver graft. Insulin dose to treat postreperfusion hyperglycemia is retrospectively analyzed using historical data. The proposed dose then is prospectively applied to the patients to assess the adequacy of the insulin dose.
Detailed description
Hyperglycemia is common during liver transplantation ,especially after graft reperfusion. Response to insulin is frequently unpredictable during postreperfusion period with no consensus or guidelines on glycemic control. The primary aim of this mixed retrospective/prospective study is to investigate the optimal insulin dose to treat hyperglycemia during the postreperfusion period of liver transplantation.
In the retrospective study, adult liver recipients (>18 years old) who underwent liver transplantation between 2004 and 2016 are reviewed. Delta glucose is the primary outcome variable defined as the difference in blood glucose levels before and after insulin administration. The relationship between the insulin dose and delta glucose is analyzed with a linear mixed effects analysis to find the optimal insulin dose to treat postreperfusion hyperglycemia.
In the prospective trial, the proposed insulin dose is administered to the patient who showed hyperglycemia after graft reperfusion. The frequency and magnitude of glucose reduction is the primary outcome. The secondary outcome is the incidence and degree of hypoglycemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study group receives a linear mixed effects model-proposed dose of insulin when hyperglycemia is noticed after reperfusion of liver graft.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: InsulinThe study group receives a linear mixed effects model-proposed dose of insulin when hyperglycemia is noticed after reperfusion of liver graft. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Liver recipients who showed hyperglycemia (blood glucose >180mg/dL) after reperfusion of liver graft.
Key exclusion criteria (1 listed)
- pediatric patients
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 |
|---|---|---|
| InsulinIf blood glucose level after reperfusion of liver graft exceeds 180 mg/dL, the insulin dose proposed by the linear mixed effects analysis is given as a bolus. | Drug | Study group |
Primary outcome
Change of blood glucose level 20 minutes after insulin administration
Time frame: 20 minutes after insulin administration
Insulin is administered immediately after baseline hyperglycemia (blood glucose >180 mg/dL) has been observed. Change of blood glucose level after insulin administration is calculated as (baseline glucose - glucose after insulin administration).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Chul-Woo Jung, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin in people with Hyperglycaemia (Diabetic) and Liver Transplantation, run by Seoul National University Hospital at 1 site in South Korea.
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 1 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 19 Apr 2024. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Chul-Woo Jung, MD, PhD (82-2-2072-0640, jungcwoo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of blood glucose level 20 minutes after insulin administration (time frame: 20 minutes after insulin administration). 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 19 Apr 2024.