Stress Hyperglycemia. Potential Role of Incretin Analogs | NCT01087372

Studies
Stress Hyperglycemia. Potential Role of Incretin Analogs

NCT01087372

Sponsor

Hospital Universitari Son Dureta

Status

Completed

Last Update Posted

Jun 8, 2010Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Hyperglycemia
Critical Illness

Interventions

Not provided

Countries

Spain

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

Jun 2010

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

Jan 2010

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Mar 11, 2010

First Submission Date that Met QC Criteria

Mar 15, 2010

First Posted Date

Mar 16, 2010Estimated

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

Jun 7, 2010

Last Update Posted Date

Jun 8, 2010Estimated

Name	Class
Fundació Mateu Orfila	UNKNOWN

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

This is a prospective observational study to examine the levels of glucoregulatory hormones, with special focus on incretins levels, in critically ill patients with stress hyperglycemia.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incretins plasmatic levels	28 days and ICU mortality	28 days

Secondary Outcomes

Measure	Description	Time Frame
glucagon	28 days and ICU mortality	28 days
insulin	28 days and ICU mortality	28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years
Emergent ICU admission
Written informed consent from patient or relative.

Exclusion Criteria:

Previously known type I or type II diabetes.
Patients who received insulin or oral antidiabetic agents before ICU admission.
Malignancies.
Scheduled surgery
Patients receiving enteral or parenteral nutrition.
Inability to obtain informed consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Medical-surgical ICU patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Juan A Llompart-Pou, M.D.	Hospital Universitari Son Dureta. Intensive Care Unit	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitari Son Dureta. Intensive Care Unit		Palma de Mallorca	Balearic Islands	07014	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22566312	Derived	Llompart-Pou JA, Fernandez-de-Castillo AG, Burguera B, Perez-Barcena J, Marse P, Rodriguez-Yago M, Barcelo A, Raurich JM. Stress hyperglycaemia in critically ill patients: potential role of incretin hormones; a preliminary study. Nutr Hosp. 2012 Jan-Feb;27(1):130-7. doi: 10.1590/S0212-16112012000100015.

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D020969	Disease Attributes

ID	Term
D006943	Hyperglycemia
D016638	Critical Illness