CancerTPNNCT02024321
Study on Blood Glucose Variations in Tumor Patients Before and After Total Parenteral Nutrition
An observational study of Cancer and Surgery, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to determine the relationship among TPN, tumor and blood glucose. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer, Surgery, Nutrition Related Cancer
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Dec 2013
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Tumor patients using TPN in abdominal surgery department in Cancer Hospital.
Who may be able to join
- 1.tumor patients,2.use TPN after surgery
Who cannot join
- without using TPN
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
Official title: Phase 1: Select Tumor Patients to be Observed Phase 2: Observe the Blood Glucose Values During TPN Phase 3: Sort Data
The purpose of this study is to determine the relationship among TPN, tumor and blood glucose.
Read the detailed description
Select the tumor patients in abdominal department after surgery with TPN. Monitor the blood glucose variation after TPN.
- Conditions
- Cancer, Surgery, Nutrition Related Cancer
- Keywords
- abdominal surgery, TPN, blood glucose
- Medical subject headings
- Neoplasms
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 |
|---|---|---|
| Tumor patients, TPN, surgery | This work involved prospective study of surgical patients receiving TPN during the calendar year of 2013 at Cancer Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Variations during TPN
Observe the blood glucose variation in tumor patients after surgery. According to the TPN infusion time, the blood glucose values are divided into three parts: pre TPN, within 24h and after 24h.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jincheng Yang, Chinese Academy of Medical Sciences
- Investigators
- Jincheng Yang, Doctor, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024321
- Sponsor's protocol ID
- TPN-tumor
- Acronym
- TPN
- Status last verified
- Dec 2013
- First submitted
- 18 Dec 2013
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pasquel FJ, Spiegelman R, McCauley M, Smiley D, Umpierrez D, Johnson R, Rhee M, Gatcliffe C, Lin E, Umpierrez E, Peng L, Umpierrez GE. Hyperglycemia during total parenteral nutrition: an important marker of poor outcome and mortality in hospitalized patients. Diabetes Care. 2010 Apr;33(4):739-41. doi: 10.2337/dc09-1748. Epub 2009 Dec 29.
PubMed 20040658Yang JC, Dai YY, Wang LM, Xie YB, Zhou HY, Li GH. Glycemic Variation in Tumor Patients with Total Parenteral Nutrition. Chin Med J (Engl). 2015 Aug 5;128(15):2034-9. doi: 10.4103/0366-6999.161358.
PubMed 26228214
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1: Select Tumor Patients to be Observed Phase 2: Observe the Blood Glucose Values During TPN Phase 3: Sort Data
- ClinicalTrials.gov ID
- NCT02024321
- Acronym / sponsor ID
- TPN / TPN-tumor
- Conditions
- Cancer, Surgery, Nutrition Related Cancer
- Keywords
- abdominal surgery, TPN, blood glucose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 31 Dec 2013 (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 determine the relationship among TPN, tumor and blood glucose.
Detailed description
Select the tumor patients in abdominal department after surgery with TPN. Monitor the blood glucose variation after TPN.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor patients, TPN, surgery | – | –This work involved prospective study of surgical patients receiving TPN during the calendar year of 2013 at Cancer Hospital. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Tumor patients using TPN in abdominal surgery department in Cancer Hospital.
Key inclusion criteria (1 listed)
- 1.tumor patients,2.use TPN after surgery
Key exclusion criteria (1 listed)
- without using TPN
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
Glycemic Variations during TPN
Time frame: 1 year
Observe the blood glucose variation in tumor patients after surgery. According to the TPN infusion time, the blood glucose values are divided into three parts: pre TPN, within 24h and after 24h.
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 31 Dec 2013.
- Background: PubMed 20040658Pasquel FJ, Spiegelman R, McCauley M, Smiley D, Umpierrez D, Johnson R, Rhee M, Gatcliffe C, Lin E, Umpierrez E, Peng L, Umpierrez GE. Hyperglycemia during total parenteral nutrition: an important marker of poor outcome and mortality in hospitalized patients. Diabetes Care. 2010 Apr;33(4):739-41. doi: 10.2337/dc09-1748. Epub 2009 Dec 29.
- Derived from this study: PubMed 26228214Yang JC, Dai YY, Wang LM, Xie YB, Zhou HY, Li GH. Glycemic Variation in Tumor Patients with Total Parenteral Nutrition. Chin Med J (Engl). 2015 Aug 5;128(15):2034-9. doi: 10.4103/0366-6999.161358.
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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.
Jincheng Yang, Doctor principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Surgery, run by Chinese Academy of Medical Sciences at 1 site in China.
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: finished, as of the sponsor's last update on 31 Dec 2013. 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 China. 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?
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?
Glycemic Variations during TPN (time frame: 1 year). 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 NCT02024321, which also lists 2 linked publications.
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 31 Dec 2013.