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

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ClinicalTrials.gov Identifier: NCT01796847
Recruitment Status : Completed
First Posted : February 22, 2013
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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. 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 or disease
Critical Illness Hyperglycemia

Study Design

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Influence of PTEN on Glycemic Variability and Clinical Outcome in the Critically Ill Patient.
Study Start Date : December 2012
Primary Completion Date : December 2014
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
PTEN, hyperglycemia


Outcome Measures

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

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

Eligibility Criteria

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


Locations
Italy
University of Rome La Sapienza, University Hospital
Rome, Italy, 00185
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 Posted: February 22, 2013    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017

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