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Relationship Between PTEN and Glycemic Variability and Outcome in Critically Ill Patients (GLUPTEN)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by Alessandro Laviano, University of Roma La Sapienza.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01796847
First Posted: February 22, 2013
Last Update Posted: December 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alessandro Laviano, University of Roma La Sapienza
  Purpose

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.


Condition
Critical Illness Hyperglycemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Influence of PTEN on Glycemic Variability and Clinical Outcome in the Critically Ill Patient.

Resource links provided by NLM:


Further study details as provided by Alessandro Laviano, University of Roma La Sapienza:

Primary Outcome Measures:
  • Length of ICU stay [ Time Frame: Day 1 up to day 28 ]

Secondary Outcome Measures:
  • Glycemic variability as expressed by standard deviation of the glycemia measurements [ Time Frame: Day 1 up to day 28 ]

Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
PTEN, hyperglycemia

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Truma patients admitted to general ICU
Criteria

Inclusion Criteria:

  • trauma
  • provision informed consent

Exclusion Criteria:

  • diabetes
  • impaired fasting glucose levels
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01796847


Contacts
Contact: Alessandro Laviano, MD +39-0649973902 alessandro.laviano@uniroma1.it

Locations
Italy
University of Rome La Sapienza, University Hospital Recruiting
Rome, Italy, 00185
Contact: Donatella Dell'Utri, MD       donatella.dellutri@uniroma1.it   
Principal Investigator: Alessandro Laviano, MD         
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Principal Investigator: Alessandro Laviano, MD Sapienza University of Rome
  More Information

Responsible Party: Alessandro Laviano, Associate Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01796847     History of Changes
Other Study ID Numbers: LAVPTEN
First Submitted: February 11, 2013
First Posted: February 22, 2013
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by Alessandro Laviano, University of Roma La Sapienza:
ICU
Hyperglycemia
Length of stay

Additional relevant MeSH terms:
Critical Illness
Hyperglycemia
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases