NCT00984737

Brief Summary

Newly diagnosed hyperglycemia (NDH) and stress hyperglycemia (SH) during acute illness is reported as a non-physiological condition in hospitals. The investigators aim is to determine the rate of NDH and SH among cases admitted to coronary ICU with acute coronary disease and to inquire the relationship of SH with disease severity and functional outcomes such as longevity of ICU stay.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started May 2007

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

May 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2009

Completed
Last Updated

September 25, 2009

Status Verified

September 1, 2009

Enrollment Period

1.5 years

First QC Date

September 24, 2009

Last Update Submit

September 24, 2009

Conditions

Diabetes MellitusHyperglycemiaBlood GlucoseMyocardial Ischemia

Outcome Measures

Primary Outcomes (1)

  • To determine the prevalence of newly diagnosed hyperglycemia in coronary ICU.

Secondary Outcomes (1)

  • To search for the cases with stress hyperglycemia and inquire its relationship with disease severity and functional outcomes, such as longevity of ICU stay.

Interventions

InsulinDRUG

Capillary glucose measurements of Group 2 and Group 3 will be performed during hospitalization and will be treated when they are over 180mg/dl. Short acting oral anti-diabetic drugs will be given to patients who refuse insulin injection.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with acute coronary syndrome (non ST segment elevation)and myocardial infarction admitted to coronary ICU only via emergency room

You may not qualify if:

  • Patients admitted to coronary ICU from other hospital wards
  • Patients with any disease that will need drugs that may interfere with blood glucose negatively (mannitol, glucocorticoids, vasopressor agents, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University Faculty of Medicine, Adana Medical Center

Adana, 01250, Turkey (Türkiye)

Location

Related Publications (5)

  • Umpierrez GE, Isaacs SD, Bazargan N, You X, Thaler LM, Kitabchi AE. Hyperglycemia: an independent marker of in-hospital mortality in patients with undiagnosed diabetes. J Clin Endocrinol Metab. 2002 Mar;87(3):978-82. doi: 10.1210/jcem.87.3.8341.

    PMID: 11889147RESULT

  • Norhammar AM, Ryden L, Malmberg K. Admission plasma glucose. Independent risk factor for long-term prognosis after myocardial infarction even in nondiabetic patients. Diabetes Care. 1999 Nov;22(11):1827-31. doi: 10.2337/diacare.22.11.1827.

    PMID: 10546015RESULT

  • McCowen KC, Malhotra A, Bistrian BR. Stress-induced hyperglycemia. Crit Care Clin. 2001 Jan;17(1):107-24. doi: 10.1016/s0749-0704(05)70154-8.

    PMID: 11219223RESULT

  • Capes SE, Hunt D, Malmberg K, Gerstein HC. Stress hyperglycaemia and increased risk of death after myocardial infarction in patients with and without diabetes: a systematic overview. Lancet. 2000 Mar 4;355(9206):773-8. doi: 10.1016/S0140-6736(99)08415-9.

    PMID: 10711923RESULT

  • Ertorer ME, Haydardedeoglu FE, Erol T, Anaforoglu I, Binici S, Tutuncu NB, Sezgin A, Demirag NG. Newly diagnosed hyperglycemia and stress hyperglycemia in a coronary intensive care unit. Diabetes Res Clin Pract. 2010 Oct;90(1):8-14. doi: 10.1016/j.diabres.2010.05.023. Epub 2010 Jul 31.

    PMID: 20674059DERIVED

MeSH Terms

Conditions

Diabetes MellitusHyperglycemiaMyocardial Ischemia

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 24, 2009

First Posted

September 25, 2009

Study Start

May 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

September 25, 2009

Record last verified: 2009-09

Locations

TU(1)