Amino Acid Supplementation in Recovery From Severe Burn (ExAA)
This study is currently recruiting participants.
Verified June 2012 by The University of Texas, Galveston
Sponsor:
The University of Texas, Galveston
Collaborator:
Shriners Hospitals for Children
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT01618630
First received: May 30, 2012
Last updated: June 11, 2012
Last verified: June 2012
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Purpose
Severe burns result in persistent and extensive fat deposition in liver and muscle tissue. This may be related to the prolonged insulin resistance observed following burn. In this study the investigators will test the hypothesis that essential amino acids act in synergy with exercise to improve liver steatosis and muscle lipid metabolism, and thus also affect insulin sensitivity. Children with burns will participate in six weeks of exercise training with/without amino acid supplementation. Before and after the intervention, measurements will be done to determine muscle and liver fat content, muscle fat and protein metabolism, and insulin sensitivity.
| Condition | Intervention |
|---|---|
|
Burn Injury |
Dietary Supplement: Dietary Supplement: Amino acids for six weeks Dietary Supplement: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Amino Acid Supplementation in Recovery From Severe Burn |
Resource links provided by NLM:
Further study details as provided by The University of Texas, Galveston:
Primary Outcome Measures:
- Fat metabolism [ Time Frame: 6 weeks of intervention (study visits at beginning and end of 6 weeks of supplementation and +/- exercise) ] [ Designated as safety issue: No ]Lipid levels, fat oxidation
Secondary Outcome Measures:
- Muscle protein metabolism [ Time Frame: 6 weeks of intervention (study visits at beginning and end of 6 weeks of supplementation and +/- exercise) ] [ Designated as safety issue: No ]Muscle protein synthesis and breakdown
- Insulin sensitivity [ Time Frame: 6 weeks of intervention (study visits at beginning and end of 6 weeks of supplementation and +/- exercise) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | October 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Amino acids
Amino acid supplementation for six weeks
|
Dietary Supplement: Dietary Supplement: Amino acids for six weeks
Amino acids in drinks between meals for six weeks.
|
|
Placebo Comparator: Placebo
Supplementation of placebo (inert components) for six weeks
|
Dietary Supplement: Placebo
Placebo supplementation as drinks in between meals for six weeks
|
Eligibility| Ages Eligible for Study: | 7 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female
- 7-17 years old
- Body weight >20 kg (based on blood requirements)
- ≥30% TBSA
- Wounds 95% healed
Exclusion Criteria:
- Respiratory insufficiency
- Multiple fractures
- History of Cancer in the last 5 years
- Diabetes Mellitus
- Bilirubin > 3 mg/dl
- Associated head injuries requiring specific therapy
- Associated injuries to chest or abdomen requiring surgery
- Serum creatinine > 3 mg/dl after fluid resuscitation
- Receipt of any experimental drug other than the ones supplied within two months of this study
- Any metal in body including rods, neurofibrilators, pacemakers, etc
- Orthopedic casting which would prevent placement of patient in MRI machine
- Hepatitis
- Abnormal EKG
- Electrical burns
- Patients unable to lie still without heavy sedation will be excluded from MRI portion.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618630
Contacts
| Contact: Debra Benjamin, RN | (409) 772-3622 | dbenjam@utmb.edu |
Locations
| United States, Texas | |
| Shriners Hospitals for Children | Recruiting |
| Galveston, Texas, United States, 77550 | |
| Contact: Elisabet Borsheim, PhD 409-770-6609 elborshe@utmb.edu | |
| Principal Investigator: Elisabet Borsheim, PhD | |
Sponsors and Collaborators
The University of Texas, Galveston
Shriners Hospitals for Children
Investigators
| Principal Investigator: | Elisabet Borsheim, PhD | UTMB, Shriners Hospitals for Children |
More Information
No publications provided
| Responsible Party: | The University of Texas, Galveston |
| ClinicalTrials.gov Identifier: | NCT01618630 History of Changes |
| Other Study ID Numbers: | 12-048 |
| Study First Received: | May 30, 2012 |
| Last Updated: | June 11, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The University of Texas, Galveston:
|
burn injury children nutrition lipid metabolism |
insulin sensitivity amino acids stable isotopes |
Additional relevant MeSH terms:
|
Burns Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013