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Stress Hyperglycemia. Potential Role of Incretin Analogs

This study has been completed.
Sponsor:
Collaborator:
Fundació Mateu Orfila
Information provided by:
Hospital Universitari Son Dureta
ClinicalTrials.gov Identifier:
NCT01087372
First received: March 11, 2010
Last updated: June 7, 2010
Last verified: June 2010
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Hospital Universitari Son Dureta:

Primary Outcome Measures:
  • Incretins plasmatic levels [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    28 days and ICU mortality


Secondary Outcome Measures:
  • glucagon [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    28 days and ICU mortality

  • insulin [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    28 days and ICU mortality

  • cortisol [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    28 days and ICU mortality

  • HOMA index [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Hospital Universitari Son Dureta

Additional 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
Study First Received: March 11, 2010
Last Updated: June 7, 2010
Health Authority: Spain: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 21, 2013