Study of High Blood Sugars and Insulin in Hospitalized, Critically Ill Children
Public ClinicalTrials.gov record NCT00487006. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Insulin Resistance Versus Absolute Insulin Deficiency: Evaluating the Mechanism of Hyperglycemia in Pediatric Critical Illness
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
BACKGROUND AND PURPOSE Critical illness hyperglycemia (CIH) - elevated blood glucose in the critically ill patient population - has gained much interest among health care providers over the past several years. Clinical studies in adults have documented a high rate of hyperglycemia in some post-surgical and medical intensive care units (ICUs). However, the primary reasons for interest in this topic are not due just to its high rate, but also to the fact that by returning the high glucose levels found in this population to normal with insulin therapy can dramatically improve clinical outcomes by decreasing both morbidity and long-term mortality. Because of this, aggressive glucose control has become common practice in adult ICU critical care management. Although there is substantial data describing the high incidence of CIH in adult patients, there is little information regarding this condition in children. A single retrospective study recently published also suggested a high incidence of CIH in children with critical illness secondary to both medical and surgical causes. It is yet to be determined if, like in adults, normalizing blood glucose levels with insulin improves outcomes in this pediatric population. Because evidence appears compelling that hyperglycemia is both common and detrimental in adults, many pediatric ICUs have likewise begun to focus on aggressively treating hyperglycemia in critically ill children. The proposed study is a prospective observational pilot study to occur in the Pediatric Intensive Care Unit (PICU) at Children's Healthcare of Atlanta at Egleston. This prospective pilot study is being done to evaluate the endocrine factors associated with, if not responsible for, CIH, and the changes that take place with the restoration of normal blood glucose levels by insulin therapy. To address these profound issues this study will pursue two interrelated Aims: Aim #1: To determine if critical illness hyperglycemia is associated with absolute insulin deficiency, peripheral insulin resistance, or both. Aim #2: To characterize the requirement of insulin required to initially restore and maintain normal blood glucose levels, and compare the changes in insulin that take place with this normalization in patients with CIH. We hypothesize that the hyperglycemic response to critical illness will be associated with abnormally low levels of insulin as compared to patients without critical illness hyperglycemia.
Study identification
- NCT ID
- NCT00487006
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 209 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 12 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2006
- Primary completion
- Jun 30, 2011
- Completion
- Jan 31, 2015
- Last update posted
- Jun 15, 2015
2006 – 2015
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Healthcare of Atlanta | Atlanta | Georgia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00487006, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 15, 2015 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00487006 live on ClinicalTrials.gov.