Diabetes MellitusNCT00984737
Hyperglycemia in a Coronary Intensive Care Unit
A study testing Insulin in people with Diabetes Mellitus and Hyperglycemia, run by Baskent University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Hyperglycemia, Blood Glucose
- What is being tested?
- Insulin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- Not given
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2007to Nov 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with acute coronary syndrome (non ST segment elevation)and myocardial infarction admitted to coronary ICU only via emergency room
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University Faculty of Medicine, Adana Medical Center
Adana, 01250
About this study
Official title: Newly Diagnosed Hyperglycemia and Stress Hyperglycemia in a Coronary Intensive Care Unit
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.
Read the detailed description
Patients with acute coronary heart disease admitted to the emergency room will be recruited consecutively. Admission plasma glucose (APG) and fasting plasma glucose (FPG); the first morning after admission, measurements will be obtained and each participant will be subjected to capillary glucose measurement (CGM) every six hours within the first day.
Patients will be separated into 4 groups:
GROUP 1: Normoglycemic cases GROUP 2: Newly diagnosed hyperglycemic cases Group 2a: Unrecognized diabetes, hbA1c: >6.0% Group 2b: Stress hyperglycemia <6.0%. GROUP 3: Known diabetes Age, gender, co-morbidities on admission, adverse outcomes in hospital, duration of stay in coronary ICU, deaths, drugs, and glucose levels will be all recorded.
Throughout the hospital stay of Group 2 and Group 3, CGMs were performed and treated when necessary (target glucose<180mg/dl).
Acute Physiology and Chronic Health Evaluation II (APACHE-II); a severity of disease classification system was used for each case.
- Conditions
- Diabetes Mellitus, Hyperglycemia, Blood Glucose, Myocardial Ischemia
- Being tested
- Insulin
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startMay 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984737
- Sponsor's protocol ID
- KA07/101
- Status last verified
- Sep 2009
- First submitted
- 24 Sep 2009
- Last updated
- 25 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11889147Norhammar 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.
PubMed 10546015McCowen 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.
PubMed 11219223Capes 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.
PubMed 10711923Ertorer 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.
PubMed 20674059
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Newly Diagnosed Hyperglycemia and Stress Hyperglycemia in a Coronary Intensive Care Unit
- ClinicalTrials.gov ID
- NCT00984737
- Acronym / sponsor ID
- KA07/101
- Conditions
- Diabetes Mellitus, Hyperglycemia, Blood Glucose, Myocardial Ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 25 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with acute coronary heart disease admitted to the emergency room will be recruited consecutively. Admission plasma glucose (APG) and fasting plasma glucose (FPG); the first morning after admission, measurements will be obtained and each participant will be subjected to capillary glucose measurement (CGM) every six hours within the first day.
Patients will be separated into 4 groups:
GROUP 1: Normoglycemic cases GROUP 2: Newly diagnosed hyperglycemic cases Group 2a: Unrecognized diabetes, hbA1c: >6.0% Group 2b: Stress hyperglycemia <6.0%. GROUP 3: Known diabetes Age, gender, co-morbidities on admission, adverse outcomes in hospital, duration of stay in coronary ICU, deaths, drugs, and glucose levels will be all recorded.
Throughout the hospital stay of Group 2 and Group 3, CGMs were performed and treated when necessary (target glucose<180mg/dl).
Acute Physiology and Chronic Health Evaluation II (APACHE-II); a severity of disease classification system was used for each case.
Study design
- Primary purpose
- Diagnosis
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with acute coronary syndrome (non ST segment elevation)and myocardial infarction admitted to coronary ICU only via emergency room
Key exclusion criteria (2 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InsulinCapillary 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. | Drug | – |
Primary outcome
To determine the prevalence of newly diagnosed hyperglycemia in coronary ICU.
1 secondary outcome
To search for the cases with stress hyperglycemia and inquire its relationship with disease severity and functional outcomes, such as longevity of ICU stay.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2009.
- Results publication: PubMed 11889147Umpierrez 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.
- Results publication: PubMed 10546015Norhammar 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.
- Results publication: PubMed 11219223McCowen 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.
- Results publication: PubMed 10711923Capes 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.
- Derived from this study: PubMed 20674059Ertorer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin in people with Diabetes Mellitus and Hyperglycemia, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the prevalence of newly diagnosed hyperglycemia in coronary ICU.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00984737, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2009.