Pancreatic DiseaseKMSNCT00735228
Tight Glycemic Control by Artificial Pancreas
A study testing Artificial pancreas in people with Pancreatic Disease and Cardiovascular Diseases, run by Kochi University at 1 site in Japan.
Trial summary
Hyperglycaemia has been repeatedly associated with risk of mortality and morbidity in the intensive care unit (ICU). The evidence currently available is in favour of a 'normal ≤ 6.1 mmol/l' level for blood glucose control in ICUs according to two large randomized control trials of Van den Berghe G and is not… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Disease, Cardiovascular Diseases
- What is being tested?
- Artificial pancreas
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2008to Aug 2012
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients who were suffering from liver, pancreas or cardio-vascular diseases, were informed of the purpose and details of the study, and written consent was obtained from them prior to enrolment.
Who cannot join
- Patient exclusion criteria included a body weight loss greater than 10% during the six months prior to surgery
- The presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal or heart disease.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kochi Medical School
Nankoku, 783-8505
Takehiro Okabayashi, MD, PhD, +81-88-880-2370, tokabaya@kochi-u.ac.jp
Kazuhiro Hanazaki, Prof, +81-88-880-2370, im31@kochi-u.ac.jp
About this study
Official title: Benefit of Tight Glycemic Control in Surgical Patients: Prospective Randomized Clinical Trial
Hyperglycaemia has been repeatedly associated with risk of mortality and morbidity in the intensive care unit (ICU). The evidence currently available is in favour of a 'normal ≤ 6.1 mmol/l' level for blood glucose control in ICUs according to two large randomized control trials of Van den Berghe G and is not supportive of J. Miles's viewpoint in this debate. In this study, the investigators would like to evaluate that the target of blood glucose level, whether is a normal level (80-110 mg/dL) or another level (140-160 mg/dL), should be set for the reduction of perioperative mortality and complications.
Read the detailed description
Our previous prospective randomized clinical trial suggested that the postoperative morbidities were reduced by tight glycemic control of a normal level for blood glucose using artificial pancreas. However, the most feared one is hypoglycaemia, which, when severe and prolonged, may cause convulsions, coma and brain damage, as well as cardiac arrhythmias. Recently, Ven den Berghe G report that the development of accurate, continuous blood glucose monitoring devices, and preferably closed-loop systems for computer-assisted blood glucose control in the ICU, will help to avoid hypoglycaemia. In our study, no hypoglycemia showed in more than 100 patients who performed perioperative tight glycemic control by artificial pancreas.
- Conditions
- Pancreatic Disease, Cardiovascular Diseases
- Being tested
- Artificial pancreas
- Keywords
- surgery, artificial pancreas, tight glycemic control, Liver
- Medical subject headings
- Pancreatic Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial pancreasDevice
Also called artificial endocrine pancreas (NIKKISO Company)
Artificial endocrine pancreas (NIKKISO Company)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Perioperative blood glucose was controlled within the normal levels (80-110 mg/dL) by artificial pancreas. Receives: Device: Artificial pancreas |
| 2 | Active comparator | Perioperative blood glucose concentration was controlled within the range from 140 to 160 mg/dL by artificial pancreas. Receives: Device: Artificial pancreas |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hypoglycemia
Measured: during hospitalization
Secondary outcomes (1)
The incidence of postoperative infectious complications and calculate the total costs during hospitalization
Measured: during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
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 Pancreatic DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kochi University
- Sponsor type
- University, hospital or other
- Collaborators
- Oita University, University of Tokushima
- Investigators
- Takehiro Okabayashi, MD, PhD, Study director, Kochi Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735228
- Sponsor's protocol ID
- GCAP0802
- Other IDs
- Kochi Medical School
- Acronym
- KMS
- Status last verified
- Aug 2008
- First submitted
- 12 Aug 2008
- Last updated
- 18 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Okabayashi T, Shima Y, Sumiyoshi T, Kozuki A, Tokumaru T, Iiyama T, Sugimoto T, Kobayashi M, Yokoyama M, Hanazaki K. Intensive versus intermediate glucose control in surgical intensive care unit patients. Diabetes Care. 2014 Jun;37(6):1516-24. doi: 10.2337/dc13-1771. Epub 2014 Mar 12.
PubMed 24623024
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Tight Glycemic Control in Surgical Patients: Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00735228
- Acronym / sponsor ID
- KMS / GCAP0802
- Conditions
- Pancreatic Disease, Cardiovascular Diseases
- Keywords
- surgery, artificial pancreas, tight glycemic control, Liver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Kochi UniversityUniversity, hospital or other
- Collaborators
- Oita University, University of Tokushima
- Study start
- Aug 2008
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 14 Aug 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.
Hyperglycaemia has been repeatedly associated with risk of mortality and morbidity in the intensive care unit (ICU). The evidence currently available is in favour of a 'normal ≤ 6.1 mmol/l' level for blood glucose control in ICUs according to two large randomized control trials of Van den Berghe G and is not supportive of J. Miles's viewpoint in this debate. In this study, the investigators would like to evaluate that the target of blood glucose level, whether is a normal level (80-110 mg/dL) or another level (140-160 mg/dL), should be set for the reduction of perioperative mortality and complications.
Detailed description
Our previous prospective randomized clinical trial suggested that the postoperative morbidities were reduced by tight glycemic control of a normal level for blood glucose using artificial pancreas. However, the most feared one is hypoglycaemia, which, when severe and prolonged, may cause convulsions, coma and brain damage, as well as cardiac arrhythmias. Recently, Ven den Berghe G report that the development of accurate, continuous blood glucose monitoring devices, and preferably closed-loop systems for computer-assisted blood glucose control in the ICU, will help to avoid hypoglycaemia. In our study, no hypoglycemia showed in more than 100 patients who performed perioperative tight glycemic control by artificial pancreas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Artificial pancreasPerioperative blood glucose was controlled within the normal levels (80-110 mg/dL) by artificial pancreas. |
| 2 | Active comparator | Device: Artificial pancreasPerioperative blood glucose concentration was controlled within the range from 140 to 160 mg/dL by artificial pancreas. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were suffering from liver, pancreas or cardio-vascular diseases, were informed of the purpose and details of the study, and written consent was obtained from them prior to enrolment.
Key exclusion criteria (2 listed)
- Patient exclusion criteria included a body weight loss greater than 10% during the six months prior to surgery
- The presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal or heart disease.
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 |
|---|---|---|
| Artificial pancreasAlso: artificial endocrine pancreas (NIKKISO Company)Artificial endocrine pancreas (NIKKISO Company) | Device | 1, 2 |
Primary outcome
The incidence of hypoglycemia
Time frame: during hospitalization
1 secondary outcome
The incidence of postoperative infectious complications and calculate the total costs during hospitalization
Time frame: during hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2008.
- Derived from this study: PubMed 24623024Okabayashi T, Shima Y, Sumiyoshi T, Kozuki A, Tokumaru T, Iiyama T, Sugimoto T, Kobayashi M, Yokoyama M, Hanazaki K. Intensive versus intermediate glucose control in surgical intensive care unit patients. Diabetes Care. 2014 Jun;37(6):1516-24. doi: 10.2337/dc13-1771. Epub 2014 Mar 12.
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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.
Takehiro Okabayashi, MD, PhD study director
Kochi Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial pancreas in people with Pancreatic Disease and Cardiovascular Diseases, run by Kochi University at 1 site in Japan.
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: status not confirmed, as of the sponsor's last update on 18 Aug 2008. 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 Japan. 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 Takehiro Okabayashi, MD, PhD (+81-88-880-2370, tokabaya@kochi-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of hypoglycemia (time frame: during hospitalization). 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 NCT00735228, 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 18 Aug 2008; AzTrials last refreshed its copy on 31 Oct 2026.