Pediatric ObesityNCT04874610
Steroid Metabolism in Obese and Non-Obese Pediatric Patients Hospitalized for Status Asthmaticus
An observational study of Pediatric Obesity and Asthma in Children, run by Duke University at 1 site in United States.
Trial summary
Single center, open-label, non-randomized study to assess the pharmacokinetic profile of methylprednisolone in healthy children 2-20 years of age admitted for asthma exacerbation. Read more about this study
- Who is it for?
- Ages 2 to 20 years
- Conditions the study is for
- Pediatric Obesity, Asthma in Children
- What is being tested?
- Methylprednisolone
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2021to 31 Mar 2022
- Phase
- Observational
- 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 2 to 20 years
- All sexes
- Child, Adult
Study population: Children and young adults 2-20 years of age who are admitted to Duke Hospital for primary reason of asthma exacerbation and are treated with methylprednisolone.
Who may be able to join
- Age between 2 years and 20 years inclusive
- Written informed consent provided by a parent or legal guardian
- Admitted to Duke Children's Hospital for primary reason of asthma exacerbation (and treated with methylprednisolone)
- BMI-percentile greater than 95th for obese subjects and BMI less than 95th percentile for non-obese subjects
Who cannot join
- Patients with suspected liver failure, renal failure, sepsis, or cardiopulmonary instability deemed by the PI.
- Receiving any extracorporeal life support including extracorporeal membrane oxygenation, ventricular assist devices, and renal replacement therapy at enrollment
- Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the data.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27705
About this study
Single center, open-label, non-randomized study to assess the pharmacokinetic profile of methylprednisolone in healthy children 2-20 years of age admitted for asthma exacerbation.
Read the detailed description
This is a prospective study aiming to characterize the pharmacokinetics of methylprednisolone in obese and non-obese children hospitalized for asthma, and to build a metabolomic profile for each cohort. The primary hypothesis is that the obese cohort will have increased methylprednisolone clearance compared to the non-obese cohort. The secondary hypothesis is that the obese cohort will have decreased amounts of 11-β-hydroxysteroid dehydrogenase in the serum which will correlate to abnormalities in steroid clearance. The tertiary hypothesis is that the obese cohort will have increased levels of branched chain amino acids and inflammatory markers which will correlate to disease severity.
- Conditions
- Pediatric Obesity, Asthma in Children
- Being tested
- Methylprednisolone
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of methylprednisolone Prescribed per Standard of care
| Study group | Role | What they receive |
|---|---|---|
| BMI > 95 | Cohort 1: greater than or equal to 95%ile body mass index Receives: Drug: Methylprednisolone | |
| BMI < 95 | Cohort 2: less than 95%ile body mass index Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Prednisolone concentration levels as measured by ELISA
Prednisolone levels at steady state concentration
Measured: 0, 24, 48, 72, 96 hours after methylprednisolone dosing
Secondary outcomes (1)
11-beta-hydroxysteroid dehydrogenase as measured by ELISA
11-beta-hydroxysteroid dehydrogenase levels
Measured: Up to 72 hours after methylprednisolone dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start16 Aug 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caitlin King, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874610
- Sponsor's protocol ID
- Pro00108152
- Status last verified
- Apr 2022
- First submitted
- 3 May 2021
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steroid Metabolism in Obese and Non-Obese Pediatric Patients Hospitalized for Status Asthmaticus
- ClinicalTrials.gov ID
- NCT04874610
- Acronym / sponsor ID
- Pro00108152
- Conditions
- Pediatric Obesity, Asthma in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 5 May 2021 (actual)
- 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.
Single center, open-label, non-randomized study to assess the pharmacokinetic profile of methylprednisolone in healthy children 2-20 years of age admitted for asthma exacerbation.
Detailed description
This is a prospective study aiming to characterize the pharmacokinetics of methylprednisolone in obese and non-obese children hospitalized for asthma, and to build a metabolomic profile for each cohort. The primary hypothesis is that the obese cohort will have increased methylprednisolone clearance compared to the non-obese cohort. The secondary hypothesis is that the obese cohort will have decreased amounts of 11-β-hydroxysteroid dehydrogenase in the serum which will correlate to abnormalities in steroid clearance. The tertiary hypothesis is that the obese cohort will have increased levels of branched chain amino acids and inflammatory markers which will correlate to disease severity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMI > 95 | – | Drug: MethylprednisoloneCohort 1: greater than or equal to 95%ile body mass index |
| BMI < 95 | – | Drug: MethylprednisoloneCohort 2: less than 95%ile body mass index |
Who may qualify
- Ages
- 2 to 20 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children and young adults 2-20 years of age who are admitted to Duke Hospital for primary reason of asthma exacerbation and are treated with methylprednisolone.
Key inclusion criteria (4 listed)
- Age between 2 years and 20 years inclusive
- Written informed consent provided by a parent or legal guardian
- Admitted to Duke Children's Hospital for primary reason of asthma exacerbation (and treated with methylprednisolone)
- BMI-percentile greater than 95th for obese subjects and BMI less than 95th percentile for non-obese subjects
Key exclusion criteria (3 listed)
- Patients with suspected liver failure, renal failure, sepsis, or cardiopulmonary instability deemed by the PI.
- Receiving any extracorporeal life support including extracorporeal membrane oxygenation, ventricular assist devices, and renal replacement therapy at enrollment
- Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the data.
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 |
|---|---|---|
| MethylprednisoloneAdministration of methylprednisolone Prescribed per Standard of care | Drug | BMI < 95, BMI > 95 |
Primary outcome
Change in Prednisolone concentration levels as measured by ELISA
Time frame: 0, 24, 48, 72, 96 hours after methylprednisolone dosing
Prednisolone levels at steady state concentration
1 secondary outcome
11-beta-hydroxysteroid dehydrogenase as measured by ELISA
Time frame: Up to 72 hours after methylprednisolone dosing
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 1 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Caitlin King, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Obesity and Asthma in Children, run by Duke University 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 4 inclusion and 3 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 1 Jul 2022. 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?
Change in Prednisolone concentration levels as measured by ELISA (time frame: 0, 24, 48, 72, 96 hours after methylprednisolone dosing). 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 1 Jul 2022.