Relationship Between PTEN and Glycemic Variability and Ou... | NCT01796847

Studies
Relationship Between PTEN and Glycemic Variability and Outcome in Critically Ill Patients

NCT01796847

Sponsor

University of Roma La Sapienza

Status

Completed

Last Update Posted

Nov 7, 2017Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Critical Illness
Hyperglycemia

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Dec 2014Actual

Completion Date

May 2015Actual

First Submitted Date

Feb 11, 2013

First Submission Date that Met QC Criteria

Feb 21, 2013

First Posted Date

Feb 22, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2017

Last Update Posted Date

Nov 7, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alessandro Laviano, Associate Professor, University of Roma La SapienzaPrincipal Investigator

Lead Sponsor

University of Roma La SapienzaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Label	Type	Description	Intervention Names
PTEN, hyperglycemia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of ICU stay		Day 1 up to day 28

Secondary Outcomes

Measure	Description	Time Frame
Glycemic variability as expressed by standard deviation of the glycemia measurements		Day 1 up to day 28

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

trauma
provision informed consent

Exclusion Criteria:

diabetes
impaired fasting glucose levels

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Truma patients admitted to general ICU

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alessandro Laviano, MD	University of Roma La Sapienza	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Rome La Sapienza, University Hospital		Rome		00185	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29154111	Derived	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.

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D044882	Glucose Metabolism Disorders

ID	Term
D016638	Critical Illness
D006943	Hyperglycemia