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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Roma La Sapienza
Information provided by (Responsible Party):
Alessandro Laviano, University of Roma La Sapienza Identifier:
First received: February 11, 2013
Last updated: December 4, 2014
Last verified: December 2014

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.

Critical Illness

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: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
PTEN, hyperglycemia


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

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 identifier: NCT01796847

Contact: Alessandro Laviano, MD +39-0649973902

University of Rome La Sapienza, University Hospital Recruiting
Rome, Italy, 00185
Contact: Donatella Dell'Utri, MD   
Principal Investigator: Alessandro Laviano, MD         
Sponsors and Collaborators
University of Roma La Sapienza
Principal Investigator: Alessandro Laviano, MD Sapienza University of Rome
  More Information

Responsible Party: Alessandro Laviano, Associate Professor, University of Roma La Sapienza Identifier: NCT01796847     History of Changes
Other Study ID Numbers: LAVPTEN 
Study First Received: February 11, 2013
Last Updated: December 4, 2014
Health Authority: Italy: Ministry of Health

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

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Glucose Metabolism Disorders
Metabolic Diseases
Pathologic Processes processed this record on May 23, 2016