BurnsNCT00137254
Insulin on Post Burn Hypermetabolism
A study testing Insulin, Stable Isotopes and Indocyanine Green in people with Burns, run by United States Army Institute of Surgical Research at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of insulin on helping burn patients recover faster from their burns. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Burns
- What is being tested?
- Insulin, Stable Isotopes and Indocyanine Green
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Aug 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 18 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Burn equal to or greater than 20% total body surface area (TBSA)
- Between the ages of 18-72 years
- Burns occurred within 14 days of coming to burn center
Who cannot join
- Heart attack within 3 months
- Have or have had cancer
- Seizure disorder
- Pregnancy
- Pre-existing arterial insufficiency
- Diabetes or known history of hypoglycemia
- Allergy to iodine or shellfish
Trial locations and contacts
1 site in 1 country.
United States1 site
US Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234
About this study
Official title: Effects of Insulin on Post Burn Hypermetabolism
The purpose of this study is to examine the effects of insulin on helping burn patients recover faster from their burns.
Read the detailed description
Severe injuries produce profound hypermetabolic stress responses which cause severe loss of lean body mass and muscle wasting, immunologic compromise, slowed wound healing, and related bone loss, all which contribute to increased morbidity, mortality, and prolonged recovery from injury. The results of hypermetabolism persist for weeks to months depending on the severity of the insult. Massive burns can cause severe catabolism and are an excellent model to study the general effects of injury on protein metabolism. Severe burns are characterized by dramatic increases in energy utilization and alterations in the metabolism of carbohydrates, fat, and protein.
Insulin treatment improves net protein synthesis in the severely burned, principally through improved muscle protein synthesis. Although controversy exist as to whether insulin is effective as an anabolic hormone through increasing protein synthesis or decreasing protein breakdown, we believe that consideration of the methods and experimental protocols used in the various studies bear consideration when evaluating this topic.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
IV insulin
Stable IsotopesDrug
IV administration of stable isotopes
Indocyanine GreenDrug
IV administration of ICG
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Insulin; Drug: Stable Isotopes; Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of euglycemic hyperinsulinemia throughout the hospital course on net muscle protein synthesis, and to relate continued muscle anabolism to improved lean body mass and improved functional recovery in severely burned patients
Measured: 45 days
To assess the relationship of insulin physiologic and molecular effects on skeletal muscle in severely burned patients
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startDec 2005
- Primary completionFeb 2007
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Institute of Surgical Research
- Sponsor type
- US federal agency
- Collaborators
- The University of Texas Medical Branch, Galveston
- Responsible party
- Sponsor
- Investigators
- Steven E Wolf, MD, Principal investigator, US Army Institute of Surgical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137254
- Sponsor's protocol ID
- H-05-004
- Other IDs
- NIH RO-1 GM063120-02
- Status last verified
- Apr 2012
- First submitted
- 25 Aug 2005
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ferrando AA, Chinkes DL, Wolf SE, Matin S, Herndon DN, Wolfe RR. A submaximal dose of insulin promotes net skeletal muscle protein synthesis in patients with severe burns. Ann Surg. 1999 Jan;229(1):11-8. doi: 10.1097/00000658-199901000-00002.
PubMed 9923795
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Insulin on Post Burn Hypermetabolism
- ClinicalTrials.gov ID
- NCT00137254
- Acronym / sponsor ID
- H-05-004
- Conditions
- Burns
- Keywords
- Severe burns, Hyperinsulinemia, Insulin, Muscle protein kinetics, Immune function, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- United States Army Institute of Surgical ResearchUS federal agency
- Collaborators
- The University of Texas Medical Branch, Galveston
- Study start
- Dec 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 29 Aug 2005 (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.
The purpose of this study is to examine the effects of insulin on helping burn patients recover faster from their burns.
Detailed description
Severe injuries produce profound hypermetabolic stress responses which cause severe loss of lean body mass and muscle wasting, immunologic compromise, slowed wound healing, and related bone loss, all which contribute to increased morbidity, mortality, and prolonged recovery from injury. The results of hypermetabolism persist for weeks to months depending on the severity of the insult. Massive burns can cause severe catabolism and are an excellent model to study the general effects of injury on protein metabolism. Severe burns are characterized by dramatic increases in energy utilization and alterations in the metabolism of carbohydrates, fat, and protein.
Insulin treatment improves net protein synthesis in the severely burned, principally through improved muscle protein synthesis. Although controversy exist as to whether insulin is effective as an anabolic hormone through increasing protein synthesis or decreasing protein breakdown, we believe that consideration of the methods and experimental protocols used in the various studies bear consideration when evaluating this topic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Insulin, Drug: Stable Isotopes, Drug: Indocyanine Green |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Burn equal to or greater than 20% total body surface area (TBSA)
- Between the ages of 18-72 years
- Burns occurred within 14 days of coming to burn center
Key exclusion criteria (7 listed)
- Heart attack within 3 months
- Have or have had cancer
- Seizure disorder
- Pregnancy
- Pre-existing arterial insufficiency
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 |
|---|---|---|
| InsulinIV insulin | Drug | A |
| Stable IsotopesIV administration of stable isotopes | Drug | A |
| Indocyanine GreenIV administration of ICG | Drug | A |
Primary outcome
To determine the effect of euglycemic hyperinsulinemia throughout the hospital course on net muscle protein synthesis, and to relate continued muscle anabolism to improved lean body mass and improved functional recovery in severely burned patients
Time frame: 45 days
To assess the relationship of insulin physiologic and molecular effects on skeletal muscle in severely burned patients
Time frame: 45 days
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 12 Apr 2012.
- Background: PubMed 9923795Ferrando AA, Chinkes DL, Wolf SE, Matin S, Herndon DN, Wolfe RR. A submaximal dose of insulin promotes net skeletal muscle protein synthesis in patients with severe burns. Ann Surg. 1999 Jan;229(1):11-8. doi: 10.1097/00000658-199901000-00002.
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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.
Steven E Wolf, MD principal investigator
US Army Institute of Surgical Research
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, Stable Isotopes and Indocyanine Green in people with Burns, run by United States Army Institute of Surgical Research at 1 site in United States.
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 3 inclusion and 7 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 12 Apr 2012. 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 United States. 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 effect of euglycemic hyperinsulinemia throughout the hospital course on net muscle protein synthesis, and to relate continued muscle anabolism to improved lean body mass and improved functional recovery in severely burned patients (time frame: 45 days). The study lists 2 primary outcomes in all. 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 NCT00137254, which also lists 1 linked publication.
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 12 Apr 2012.