Critical IllnessGLUPTENNCT01796847
Relationship Between PTEN and Glycemic Variability and Outcome in Critically Ill Patients
An observational study of Critical Illness and Hyperglycemia, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Glycemic variability in critically ill patients is a recognized negative prognostic factor. The molecular mechanisms determining inter-patients variability in glucose metabolism during stress are not fully understood. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Critical Illness, Hyperglycemia
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2012to May 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Truma patients admitted to general ICU
Who may be able to join
- trauma
- provision informed consent
Who cannot join
- diabetes
- impaired fasting glucose levels
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of PTEN on Glycemic Variability and Clinical Outcome in the Critically Ill Patient.
Glycemic variability in critically ill patients is a recognized negative prognostic factor. The molecular mechanisms determining inter-patients variability in glucose metabolism during stress are not fully understood. The Phosphatase and Tensin homolog (PTEN) is known to influence glucose homeostasis by interfering in intracellular insulin signaling.
Aim of this study is to ascertain whether differential expression of PTEN in critically ill patients correlates with glycemic variability and clinical outcome.
- Conditions
- Critical Illness, Hyperglycemia
- Keywords
- ICU, Hyperglycemia, Length of stay
- Medical subject headings
- Critical Illness, Hyperglycemia
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 |
|---|---|---|
| PTEN, hyperglycemia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of ICU stay
Measured: Day 1 up to day 28
Secondary outcomes (1)
Glycemic variability as expressed by standard deviation of the glycemia measurements
Measured: Day 1 up to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2014
- Study completionMay 2015
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 Critical IllnessStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Laviano, University of Roma La Sapienza
- Investigators
- Alessandro Laviano, MD, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796847
- Sponsor's protocol ID
- LAVPTEN
- Acronym
- GLUPTEN
- Status last verified
- Nov 2017
- First submitted
- 11 Feb 2013
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Molfino A, Alessandri F, Mosillo P, Dell'Utri D, Farcomeni A, Amabile MI, Laviano A. PTEN expression and its association with glucose control and calorie supplementation in critically ill patients. Clin Nutr. 2018 Dec;37(6 Pt A):2186-2190. doi: 10.1016/j.clnu.2017.10.021. Epub 2017 Nov 4.
PubMed 29154111
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of PTEN on Glycemic Variability and Clinical Outcome in the Critically Ill Patient.
- ClinicalTrials.gov ID
- NCT01796847
- Acronym / sponsor ID
- GLUPTEN / LAVPTEN
- Conditions
- Critical Illness, Hyperglycemia
- Keywords
- ICU, Hyperglycemia, Length of stay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 22 Feb 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.
Glycemic variability in critically ill patients is a recognized negative prognostic factor. The molecular mechanisms determining inter-patients variability in glucose metabolism during stress are not fully understood. The Phosphatase and Tensin homolog (PTEN) is known to influence glucose homeostasis by interfering in intracellular insulin signaling.
Aim of this study is to ascertain whether differential expression of PTEN in critically ill patients correlates with glycemic variability and clinical outcome.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTEN, hyperglycemia | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Truma patients admitted to general ICU
Key inclusion criteria (2 listed)
- trauma
- provision informed consent
Key exclusion criteria (2 listed)
- diabetes
- impaired fasting glucose levels
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
Length of ICU stay
Time frame: Day 1 up to day 28
1 secondary outcome
Glycemic variability as expressed by standard deviation of the glycemia measurements
Time frame: Day 1 up to day 28
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 7 Nov 2017.
- Derived from this study: PubMed 29154111Molfino A, Alessandri F, Mosillo P, Dell'Utri D, Farcomeni A, Amabile MI, Laviano A. PTEN expression and its association with glucose control and calorie supplementation in critically ill patients. Clin Nutr. 2018 Dec;37(6 Pt A):2186-2190. doi: 10.1016/j.clnu.2017.10.021. Epub 2017 Nov 4.
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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.
Alessandro Laviano, MD principal investigator
University of Roma La Sapienza
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 Critical Illness and Hyperglycemia, run by University of Roma La Sapienza at 1 site in Italy.
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 2 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: finished, as of the sponsor's last update on 7 Nov 2017. 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 Italy. 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?
Length of ICU stay (time frame: Day 1 up to day 28). 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 NCT01796847, 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 7 Nov 2017.