Status:
COMPLETED
Substrate Cycling in Energy Metabolism
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
Shriners Hospitals for Children
Conditions:
Burns
Insulin Resistance
Eligibility:
All Genders
4-18 years
Phase:
PHASE2
Brief Summary
Insulin resistance and hyperglycemia contribute to negative outcomes in burned patients. We will assess insulin sensitivity in traditional terms of glucose metabolism, and with regard to the responsiv...
Detailed Description
We will study patients with severe burns, defined as 2nd or 3rd degree burn covering \>40% of total body surface area (TBSA). We propose to study burned children from Shriners Burns Hospital. The Shri...
Eligibility Criteria
Inclusion
- We will study male and female burned patients from 20 KG (based on blood requirement) in weight. Patients will be studied between days 12-15 after the initial surgery and will have burns constituting \>40% of the body surface. Volunteers will be determined as healthy utilizing history, physical examination and screening laboratory values assessing liver and renal function, coagulation and platelet function.
Exclusion
- Sulfide or iodide allergies 2.Respiratory Insufficiency 3.Multiple Fractures 4.History of Cancer in the last 5 years 5.Diabetes Mellitus 6.Bilirubin \>3.0 mg/dl 7.Associated head injuries requiring specific therapy 8.Associated injuries to chest or abdomen requiring surgery 9.Serum creatine \> 3.0 mg/dl after fluid resuscitation 10.Receipt of any experimental drug other than ones supplied with two months of this study 11.Any metal in body including rods, neurofibrilators, pacemakers, etc. 12.Orthopedic casting which would prevent placement in MRI 13.Hepatitis 14.Abnormal EKG 17. Bruits over the femoral artery 18. Electrical burn 19. Patients unable to lie still without heavy sedation will not be used for the MRS portion of the study.
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Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00361751
Start Date
May 1 2003
End Date
May 1 2005
Last Update
February 15 2010
Active Locations (1)
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1
Shriners Hospital for CHildren
Galveston, Texas, United States, 77550