NCT01796847

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

2 years

First QC Date

February 11, 2013

Last Update Submit

November 3, 2017

Conditions

Critical IllnessHyperglycemia

Keywords

ICUHyperglycemiaLength of stay

Outcome Measures

Primary Outcomes (1)

  • Length of ICU stay

    Day 1 up to day 28

Secondary Outcomes (1)

  • Glycemic variability as expressed by standard deviation of the glycemia measurements

    Day 1 up to day 28

Study Arms (1)

PTEN, hyperglycemia

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Truma patients admitted to general ICU

You may qualify if:

  • trauma
  • provision informed consent

You may not qualify if:

  • diabetes
  • impaired fasting glucose levels

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rome La Sapienza, University Hospital

Rome, 00185, Italy

Location

Related Publications (1)

  • 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.

    PMID: 29154111DERIVED

MeSH Terms

Conditions

Critical IllnessHyperglycemia

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Alessandro Laviano, MD

    University of Roma La Sapienza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 11, 2013

First Posted

February 22, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2014

Study Completion

May 1, 2015

Last Updated

November 7, 2017

Record last verified: 2017-11

Locations

IT(1)