Second or Third Degree BurnsPhase 4NCT01574131
Acute and Long-Term Outcome Investigations of Fenofibrate on Severely Burned Patients
A Phase 4 study testing Fenofibrate and Sugar Pill in people with Second or Third Degree Burns, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The purpose of this study is to learn the following: whether long-term treatment (6 months) with fenofibrate will decrease burn related sugar and fat increased in the blood and help prevent muscle loss and improve wound healing. Read more about this study
- Who is it for?
- Ages 4 to 20 years
- Conditions the study is for
- Second or Third Degree Burns
- What is being tested?
- Fenofibrate and Sugar Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Feb 2016
- Phase
- Phase 4
- 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 4 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ≥40% Burn
- ages 4-20years
- body weight ≥10kg
Who cannot join
- <40% burn
- ages <4->20 years
- body weight <10kg
- Respiratory insufficiency
- Multiple fractures
- History of cancer in last 5 years
Show all 18Show fewer
- Bilirubin>3mg/dL
- Serum Creatinine>3mg/dL after fluid resuscitation
- Glutamyl-Oxaloacetic Transaminase(GOT) >40 Units/L
- Glutamyl-Pyruvate Transminase(GPT) >51 Units/L
- Associated head injuries requiring therapy
- Associated injuries to the chest or abdomen requiring surgery
- Receipt of any experimental drug other than the ones supplied within two months of study
- Any metal in body including rods, cardiac defibrillators, pacemaker, etc
- Orthopedic casting which would prevent placement in MRI
- Hepatitis
- Abnormal EKG
- Electrical burns
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77551
About this study
The purpose of this study is to learn the following: whether long-term treatment (6 months) with fenofibrate will decrease burn related sugar and fat increased in the blood and help prevent muscle loss and improve wound healing.
Read the detailed description
Following severe burn injury in human patients the mitochondrial fat oxygenation capacity is decreased in muscle. This is associated with a corresponding progression in the severity of the resistance to the action of insulin on glucose disposal and protein synthesis and breakdown in muscle, regenerating wound and liver.
Fatty acids or their active intracellular products ( e.g. Diacylglycerol, acyl- Coenzyme A(CoA) or acylcarnitine) are the direct inhibitors of insulin action, rather than tissue triglycerides(TG) itself. In other words, impaired mitochondrial fatty acid oxygenation is the mechanism that causes altered lipid metabolism that ultimately contributes to insulin resistance.
Accumulation of active fatty acid products, such as Diacylglycerol, acyl-CoA or acylcarnitine esters in muscle cells is due to the rate of uptake of plasma free fatty acids(FFA) exceeding the rate of oxygenation within muscle due principally to a reduced capacity of mitochondria to oxidize fatty acids.
Decreasing insulin sensitivity in muscle is related to impaired insulin signaling. This will be reflected by increased activity of protein kinase C (PKC). Because PKC is thought to exert its regulatory effect primarily on either tyrosine kinase activity on the insulin receptor or downstream kinase insulin receptor substrate (IRS) phosphorylation, these elements of the insulin signaling cascade will be decreased. In turn, elements of insulin signaling related to the response of muscle glucose (PI3 Kinase) and protein (P70S6k)metabolism will be reduced. The investigators propose that increased tissue PKC activity will be associated with increased tissue concentration of Diacylglycerol, acyl-CoA or acylcarnitine. The investigators hypothesize that the treatment of patients with the peroxisome proliferator-activated receptor (PPAR) alpha antagonist fenofibrate will improve mitochondrial capacity to oxidize fatty acids. Insulin sensitivity in muscle, skin and liver in terms of both glucose and protein metabolism will be improved by fenofibrate treatment.
- Conditions
- Second or Third Degree Burns
- Being tested
- Fenofibrate, Sugar Pill
- Keywords
- Burn, Fenofibrate, PPAR alpha agonist, insulin sensitivity, mitochondrial
- Medical subject headings
- Neoplasm Metastasis, Burns, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenofibrateDrug
Also called Lofibra
Pill 54 mg or 160 mg tablets every day for 6 months Dosing-5mg/kg up to 160 mg for 6 months
Sugar PillDrug
Also called Placebo
pill every day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill | Placebo comparator | pill Receives: Drug: Sugar Pill |
| Fenofibrate | Active comparator | ppar-alpha agonist Receives: Drug: Fenofibrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitochondrial fatty acid oxygenation
Changes in mitochondrial oxygen consumption, Palmitoyl-CoA, palmitoyl-L-Carnitine, Pyruvate, Malate, Malonyl-CoA
Measured: 6 months post injury
Secondary outcomes (4)
Insulin sensitivity
Muscle amino acid uptake, protein synthesis and breakdown. Insulin receptor tyrosine kinase activity, insulin receptor substrate activity,protein kinase C activity,glucose uptake and enrichment. Fractioned synthetic rate of plasma proteins
Measured: 6month post injury
Protein Metabolism
Measured: 6 months post injury
Glucose Metabolism
Measured: 6 months post injury
Amino Acid Metabolism
Measured: 6 months post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: lost funding; Shriner Burn Hosp has revoked access to study records. No updates or results can be submitted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Second or Third Degree BurnsStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Responsible party
- Sponsor
- Investigators
- David N Herndon, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574131
- Sponsor's protocol ID
- 11-106
- Status last verified
- Feb 2016
- First submitted
- 22 Mar 2012
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Long-Term Outcome Investigations of Fenofibrate on Severely Burned Patients
- ClinicalTrials.gov ID
- NCT01574131
- Acronym / sponsor ID
- 11-106
- Conditions
- Second or Third Degree Burns
- Keywords
- Burn, Fenofibrate, PPAR alpha agonist, insulin sensitivity, mitochondrial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lost funding; Shriner Burn Hosp has revoked access to study records. No updates or results can be submitted
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Study start
- May 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 10 Apr 2012 (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 learn the following: whether long-term treatment (6 months) with fenofibrate will decrease burn related sugar and fat increased in the blood and help prevent muscle loss and improve wound healing.
Detailed description
Following severe burn injury in human patients the mitochondrial fat oxygenation capacity is decreased in muscle. This is associated with a corresponding progression in the severity of the resistance to the action of insulin on glucose disposal and protein synthesis and breakdown in muscle, regenerating wound and liver.
Fatty acids or their active intracellular products ( e.g. Diacylglycerol, acyl- Coenzyme A(CoA) or acylcarnitine) are the direct inhibitors of insulin action, rather than tissue triglycerides(TG) itself. In other words, impaired mitochondrial fatty acid oxygenation is the mechanism that causes altered lipid metabolism that ultimately contributes to insulin resistance.
Accumulation of active fatty acid products, such as Diacylglycerol, acyl-CoA or acylcarnitine esters in muscle cells is due to the rate of uptake of plasma free fatty acids(FFA) exceeding the rate of oxygenation within muscle due principally to a reduced capacity of mitochondria to oxidize fatty acids.
Decreasing insulin sensitivity in muscle is related to impaired insulin signaling. This will be reflected by increased activity of protein kinase C (PKC). Because PKC is thought to exert its regulatory effect primarily on either tyrosine kinase activity on the insulin receptor or downstream kinase insulin receptor substrate (IRS) phosphorylation, these elements of the insulin signaling cascade will be decreased. In turn, elements of insulin signaling related to the response of muscle glucose (PI3 Kinase) and protein (P70S6k)metabolism will be reduced. The investigators propose that increased tissue PKC activity will be associated with increased tissue concentration of Diacylglycerol, acyl-CoA or acylcarnitine. The investigators hypothesize that the treatment of patients with the peroxisome proliferator-activated receptor (PPAR) alpha antagonist fenofibrate will improve mitochondrial capacity to oxidize fatty acids. Insulin sensitivity in muscle, skin and liver in terms of both glucose and protein metabolism will be improved by fenofibrate treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar pill | Placebo comparator | Drug: Sugar Pillpill |
| Fenofibrate | Active comparator | Drug: Fenofibrateppar-alpha agonist |
Who may qualify
- Ages
- 4 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- ≥40% Burn
- ages 4-20years
- body weight ≥10kg
Key exclusion criteria (18 listed)
- <40% burn
- ages <4->20 years
- body weight <10kg
- Respiratory insufficiency
- Multiple fractures
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 |
|---|---|---|
| FenofibrateAlso: LofibraPill 54 mg or 160 mg tablets every day for 6 months Dosing-5mg/kg up to 160 mg for 6 months | Drug | Fenofibrate |
| Sugar PillAlso: Placebopill every day for 6 months | Drug | Sugar pill |
Primary outcome
Mitochondrial fatty acid oxygenation
Time frame: 6 months post injury
Changes in mitochondrial oxygen consumption, Palmitoyl-CoA, palmitoyl-L-Carnitine, Pyruvate, Malate, Malonyl-CoA
4 secondary outcomes
Insulin sensitivity
Time frame: 6month post injury
Protein Metabolism
Time frame: 6 months post injury
Glucose Metabolism
Time frame: 6 months post injury
Amino Acid Metabolism
Time frame: 6 months post injury
Results and safety
The study was stopped early (reason given: lost funding; Shriner Burn Hosp has revoked access to study records. No updates or results can be submitted). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
Related trials for Second or Third Degree Burns
Not yet recruitingObservational study
The Use of Cultured (Dermal) Epithelial Autografts in Severely Burned Patients
Burn Degree Second, Burn Degree Third
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.
David N Herndon, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fenofibrate and Sugar Pill in people with Second or Third Degree Burns, run by The University of Texas Medical Branch, Galveston 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 18 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: stopped early, as of the sponsor's last update on 29 Nov 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lost funding; Shriner Burn Hosp has revoked access to study records. No updates or results can be submitted). Results are not available in the source record.
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?
Mitochondrial fatty acid oxygenation (time frame: 6 months post injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2019.