Stress Hyperglycemia. Potential Role of Incretin Analogs

Critical Illness Clinical Trial

Official title:

Stress Hyperglycemia in Critically Ill Patients. Potential Role of Incretin Analogs. A Preliminary Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087372
• Other study ID #: Incretins2010
• Status: Completed
• Phase: N/A
• First received: March 11, 2010
• Last updated: June 7, 2010
• Start date: January 2010
• Est. completion date: April 2010

Study information

• Verified date: June 2010
• Source: Hospital Universitari Son Dureta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Hyperglycemia

Locations

Country	Name	City	State
Spain	Hospital Universitari Son Dureta. Intensive Care Unit	Palma de Mallorca	Illes Balears

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari Son Dureta	Fundació Mateu Orfila

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incretins plasmatic levels	28 days and ICU mortality	28 days	No
Secondary	glucagon	28 days and ICU mortality	28 days	No
Secondary	insulin	28 days and ICU mortality	28 days	No
Secondary	cortisol	28 days and ICU mortality	28 days	No
Secondary	HOMA index	28 days and ICU mortality	28 days	No