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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Alessandro Laviano, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01796847
First received: February 11, 2013
Last updated: February 21, 2013
Last verified: February 2013
  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 University of Roma La Sapienza:

Primary Outcome Measures:
  • Length of ICU stay [ Time Frame: Day 1 up to day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glycemic variability as expressed by standard deviation of the glycemia measurements [ Time Frame: Day 1 up to day 28 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
PTEN, hyperglycemia

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Alessandro Laviano, Associate Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01796847     History of Changes
Other Study ID Numbers: LAVPTEN
Study First Received: February 11, 2013
Last Updated: February 21, 2013
Health Authority: Italy: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 23, 2014