Liver DiseasePhase 4NCT00657124
Effect of Preoperative Supplementation in Insulin Resistance
A Phase 4 study testing Aminolevan EN in people with Liver Disease, run by Kochi University at 1 site in Japan.
Trial summary
To elucidate the effect of preoperative supplementation of carbohydrate and branched-chain amino acids on postoperative insulin resistance in patients undergoing hepatic resection, we set a randomized trial. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Disease
- What is being tested?
- Aminolevan EN
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2007to Dec 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The present study employed 26 patients, who underwent elective liver resection for hepatocellular carcinoma or adenocarcinoma.
Who cannot join
- body weight loss greater than 10 per cent during 6 months prior to the surgery
- distant metastasis
- or seriously impaired function of vital organs due to respiratory, renal or heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Oral Supplementation of Carbohydrate and Branched-Chain Amino Acids-Enriched Nutrient Improves Insulin Resistance in Patients With Hepatectomy; Prospective Randomized Clinical Trial by Using Artificial Pancreas
To elucidate the effect of preoperative supplementation of carbohydrate and branched-chain amino acids on postoperative insulin resistance in patients undergoing hepatic resection, we set a randomized trial.
Read the detailed description
Twenty-six patients with hepatectomy due to a live tumor were prospectively randomized to receive a preoperative supplementation with carbohydrate and branched-chain amino acids-enriched nutrient or not.
- Conditions
- Liver Disease
- Being tested
- Aminolevan EN, Placebo
- Keywords
- AEN
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminolevan ENDietary supplement
The present study used carbohydrate and BCAA-enriched soft-powder nutrient-mixture for preoperative supplementation. Supplementation with Aminolevan EN (100 g per day) started at two weeks prior to the surgery under the careful monitoring of compliance.
PlaceboDietary supplement
Also called No receive, normal diet
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | receive a preoperative supplementation with carbohydrate and branched-chain amino acids-enriched nutrient Receives: Dietary Supplement: Aminolevan EN |
| 2 | Placebo comparator | receive a preoperative supplementation without carbohydrate and branched-chain amino acids-enriched nutrient Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the total amount of insulin required for glycemic control after hepatic resection
Measured: total amount of insulin required
Secondary outcomes (1)
to investigate the trends of postoperative blood glucose levels and the incidence of severe hypoglycemia (< 40 mg/dL) by using artificial pancreas during intensive care unit stay
Measured: hypoglycemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startApr 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kochi University
- Sponsor type
- University, hospital or other
- Investigators
- Takehiro Okabayashi, MD, Study director, Kochi Medical School, Kochi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657124
- Sponsor's protocol ID
- PEA-AP-01
- Other IDs
- Kochi University
- Status last verified
- Apr 2008
- First submitted
- 7 Apr 2008
- Last updated
- 14 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Oral Supplementation of Carbohydrate and Branched-Chain Amino Acids-Enriched Nutrient Improves Insulin Resistance in Patients With Hepatectomy; Prospective Randomized Clinical Trial by Using Artificial Pancreas
- ClinicalTrials.gov ID
- NCT00657124
- Acronym / sponsor ID
- PEA-AP-01
- Conditions
- Liver Disease
- Keywords
- AEN
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Kochi UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 14 Apr 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.
To elucidate the effect of preoperative supplementation of carbohydrate and branched-chain amino acids on postoperative insulin resistance in patients undergoing hepatic resection, we set a randomized trial.
Detailed description
Twenty-six patients with hepatectomy due to a live tumor were prospectively randomized to receive a preoperative supplementation with carbohydrate and branched-chain amino acids-enriched nutrient or not.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Aminolevan ENreceive a preoperative supplementation with carbohydrate and branched-chain amino acids-enriched nutrient |
| 2 | Placebo comparator | Dietary Supplement: Placeboreceive a preoperative supplementation without carbohydrate and branched-chain amino acids-enriched nutrient |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The present study employed 26 patients, who underwent elective liver resection for hepatocellular carcinoma or adenocarcinoma.
Key exclusion criteria (3 listed)
- body weight loss greater than 10 per cent during 6 months prior to the surgery
- distant metastasis
- 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 |
|---|---|---|
| Aminolevan ENThe present study used carbohydrate and BCAA-enriched soft-powder nutrient-mixture for preoperative supplementation. Supplementation with Aminolevan EN (100 g per day) started at two weeks prior to the surgery under the careful monitoring of compliance. | Dietary supplement | 1 |
| PlaceboAlso: No receive, normal dietplacebo | Dietary supplement | 2 |
Primary outcome
to evaluate the total amount of insulin required for glycemic control after hepatic resection
Time frame: total amount of insulin required
1 secondary outcome
to investigate the trends of postoperative blood glucose levels and the incidence of severe hypoglycemia (< 40 mg/dL) by using artificial pancreas during intensive care unit stay
Time frame: hypoglycemia
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 14 Apr 2008.
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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 study director
Kochi Medical School, Kochi University
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 Aminolevan EN in people with Liver Disease, 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 3 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 14 Apr 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. Some participants in this study may receive a placebo. 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?
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?
to evaluate the total amount of insulin required for glycemic control after hepatic resection (time frame: total amount of insulin required). 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 14 Apr 2008.