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Stress Hyperglycemia. Potential Role of Incretin Analogs

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ClinicalTrials.gov Identifier: NCT01087372
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : June 8, 2010
Sponsor:
Collaborator:
Fundació Mateu Orfila
Information provided by:
Hospital Universitari Son Dureta

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.

Condition or disease
Hyperglycemia Critical Illness

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Stress Hyperglycemia in Critically Ill Patients. Potential Role of Incretin Analogs. A Preliminary Study
Study Start Date : January 2010
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia
U.S. FDA Resources




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


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

  2. insulin [ Time Frame: 28 days ]
    28 days and ICU mortality

  3. cortisol [ Time Frame: 28 days ]
    28 days and ICU mortality

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


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


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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.

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

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 Posted: March 16, 2010    Key Record Dates
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