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Stress Hyperglycemia. Potential Role of Incretin Analogs

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01087372
First Posted: March 16, 2010
Last Update Posted: June 8, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundació Mateu Orfila
Information provided by:
Hospital Universitari Son Dureta
  Purpose
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.

Condition
Hyperglycemia Critical Illness

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Stress Hyperglycemia in Critically Ill Patients. Potential Role of Incretin Analogs. A Preliminary Study

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Son Dureta:

Primary Outcome Measures:
  • Incretins plasmatic levels [ Time Frame: 28 days ]
    28 days and ICU mortality


Secondary Outcome Measures:
  • glucagon [ Time Frame: 28 days ]
    28 days and ICU mortality

  • insulin [ Time Frame: 28 days ]
    28 days and ICU mortality

  • cortisol [ Time Frame: 28 days ]
    28 days and ICU mortality

  • HOMA index [ Time Frame: 28 days ]
    28 days and ICU mortality


Biospecimen Retention:   Samples Without DNA
Plasma and serum samples to analyze glucorregulatory hormones.

Estimated Enrollment: 60
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Medical-surgical ICU patients
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087372


Locations
Spain
Hospital Universitari Son Dureta. Intensive Care Unit
Palma de Mallorca, Illes Balears, Spain, 07014
Sponsors and Collaborators
Hospital Universitari Son Dureta
Fundació Mateu Orfila
Investigators
Principal Investigator: Juan A Llompart-Pou, M.D. Hospital Universitari Son Dureta. Intensive Care Unit
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Juan A Llompart-Pou, Hospital Universitari Son Dureta
ClinicalTrials.gov Identifier: NCT01087372     History of Changes
Other Study ID Numbers: Incretins2010
First Submitted: March 11, 2010
First Posted: March 16, 2010
Last Update Posted: June 8, 2010
Last Verified: June 2010

Keywords provided by Hospital Universitari Son Dureta:
Stress hyperglycemia
Incretins
GLP-1
GIP
glucoregulatory hormones

Additional relevant MeSH terms:
Hyperglycemia
Critical Illness
Glucose Metabolism Disorders
Metabolic Diseases
Disease Attributes
Pathologic Processes
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs