NCT01087372

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2010

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

June 8, 2010

Status Verified

June 1, 2010

Enrollment Period

3 months

First QC Date

March 11, 2010

Last Update Submit

June 7, 2010

Conditions

HyperglycemiaCritical Illness

Keywords

Stress hyperglycemiaIncretinsGLP-1GIPglucoregulatory hormones

Outcome Measures

Primary Outcomes (1)

  • Incretins plasmatic levels

    28 days and ICU mortality

    28 days

Secondary Outcomes (4)

  • glucagon

    28 days

  • insulin

    28 days

  • cortisol

    28 days

  • HOMA index

    28 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Medical-surgical ICU patients

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Son Dureta. Intensive Care Unit

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

Related Publications (1)

  • 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.

    PMID: 22566312DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum samples to analyze glucorregulatory hormones.

MeSH Terms

Conditions

HyperglycemiaCritical Illness

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Juan A Llompart-Pou, M.D.

    Hospital Universitari Son Dureta. Intensive Care Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 11, 2010

First Posted

March 16, 2010

Study Start

January 1, 2010

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

June 8, 2010

Record last verified: 2010-06

Locations

ES(1)