Pediatric ObesityPMMRNCT02959034
Pediatric Metabolism and Microbiome Repository
An observational study of Pediatric Obesity, run by Duke University at 1 site in United States.
Trial summary
The aim of this project is to establish a bio-repository of diverse specimen types to provide investigators access to specimens in order to further research related to metabolism and the microbiome in the pediatric population. Read more about this study
- Who is it for?
- Ages 10 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- How many people
- 486 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 13 Jan 2021
- 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 10 to 23 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Samples will be collected upon consent from the patient poplation of the Healthy Lifestyles Program at Duke for the care of children with obesity, a sibling of a patient in the Healthy Lifestyles Program, or is a patient at Duke Children's Primary Care.
Who may be able to join
- Patients of the Healthy Lifestyles Program at Duke for the care of children with obesity, a sibling of a patient in the Healthy Lifestyles Program, or is a patient at Duke Children's Primary Care.
Who cannot join
- Pregnant females.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
The aim of this project is to establish a bio-repository of diverse specimen types to provide investigators access to specimens in order to further research related to metabolism and the microbiome in the pediatric population.
Read the detailed description
Human microbial cell lines, stool and/or DNA and RNA will be collected from participants 10-18 years with a BMI greater than 95th percentile and their healthy siblings.
Specimens will be collected at 3 time points over a seven month period. Healthy siblings will provide just one blood and stool sample. Samples will be maintained at the Duke Medical Science Research Laboratory.
- Conditions
- Pediatric Obesity
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BMI > 95% | No Intervention | |
| Healthy Weight Siblings | Control | |
| Healthy Weight Unrelated | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measure of abnormal metabolism using a sample biorepository
measures of metabolomics using a sample biorepository
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startSep 2016
- Primary completion13 Jan 2021
- Study completion13 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah C Armstrong, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959034
- Sponsor's protocol ID
- Pro00074547
- Other IDs
- 1R24DK110492-01
- Acronym
- PMMR
- Status last verified
- Jun 2021
- First submitted
- 29 Sep 2016
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymized data may be shared at investigators discretion following submission of request, receipt of a data transfer agreement and local IRB approval
Publications
McCann JR, Yang C, Bihlmeyer NA, Tang R, Truong T, Zhou W, An J, Jawahar J, Ilkayeva O, Muehlbauer MJ, Hu Z, Dressman HK, Poppe L, Granek JA, Arnold JW, David LA, Oh J, Shi P, Gumus Balikcioglu P, Shah SH, Armstrong SC, Newgard CB, Seed PC, Rawls JF. Branched chain amino acid metabolism and microbiome in adolescents with obesity during weight loss therapy. J Clin Invest. 2026 Jul 15;136(14):e196742. doi: 10.1172/JCI196742. eCollection 2026 Jul 15.
PubMed 42454489McCann JR, Yang C, Bihlmeyer NA, Tang R, Truong T, An J, Jawahar J, Ilkayeva O, Muehlbauer MJ, Hu Z, Dressman HK, Poppe L, Granek JA, David LA, Shi P, Balikcioglu PG, Shah SH, Armstrong SC, Newgard CB, Seed PC, Rawls JF. Branched chain amino acid metabolism and microbiome in adolescents with obesity during weight loss therapy. medRxiv [Preprint]. 2025 Jun 9:2025.02.03.25321363. doi: 10.1101/2025.02.03.25321363.
PubMed 39974080
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Metabolism and Microbiome Repository
- ClinicalTrials.gov ID
- NCT02959034
- Acronym / sponsor ID
- PMMR / Pro00074547
- Conditions
- Pediatric Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2016
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 13 Jan 2021 (actual)
- First posted
- 8 Nov 2016 (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 aim of this project is to establish a bio-repository of diverse specimen types to provide investigators access to specimens in order to further research related to metabolism and the microbiome in the pediatric population.
Detailed description
Human microbial cell lines, stool and/or DNA and RNA will be collected from participants 10-18 years with a BMI greater than 95th percentile and their healthy siblings.
Specimens will be collected at 3 time points over a seven month period. Healthy siblings will provide just one blood and stool sample. Samples will be maintained at the Duke Medical Science Research Laboratory.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BMI > 95% | – | –No Intervention |
| Healthy Weight Siblings | – | –Control |
| Healthy Weight Unrelated | – | –Control |
Who may qualify
- Ages
- 10 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Samples will be collected upon consent from the patient poplation of the Healthy Lifestyles Program at Duke for the care of children with obesity, a sibling of a patient in the Healthy Lifestyles Program, or is a patient at Duke Children's Primary Care.
Key inclusion criteria (1 listed)
- Patients of the Healthy Lifestyles Program at Duke for the care of children with obesity, a sibling of a patient in the Healthy Lifestyles Program, or is a patient at Duke Children's Primary Care.
Key exclusion criteria (1 listed)
- Pregnant females.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The measure of abnormal metabolism using a sample biorepository
Time frame: 5 years
measures of metabolomics using a sample biorepository
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 18 Jun 2021.
- Derived from this study: PubMed 42454489McCann JR, Yang C, Bihlmeyer NA, Tang R, Truong T, Zhou W, An J, Jawahar J, Ilkayeva O, Muehlbauer MJ, Hu Z, Dressman HK, Poppe L, Granek JA, Arnold JW, David LA, Oh J, Shi P, Gumus Balikcioglu P, Shah SH, Armstrong SC, Newgard CB, Seed PC, Rawls JF. Branched chain amino acid metabolism and microbiome in adolescents with obesity during weight loss therapy. J Clin Invest. 2026 Jul 15;136(14):e196742. doi: 10.1172/JCI196742. eCollection 2026 Jul 15.
- Derived from this study: PubMed 39974080McCann JR, Yang C, Bihlmeyer NA, Tang R, Truong T, An J, Jawahar J, Ilkayeva O, Muehlbauer MJ, Hu Z, Dressman HK, Poppe L, Granek JA, David LA, Shi P, Balikcioglu PG, Shah SH, Armstrong SC, Newgard CB, Seed PC, Rawls JF. Branched chain amino acid metabolism and microbiome in adolescents with obesity during weight loss therapy. medRxiv [Preprint]. 2025 Jun 9:2025.02.03.25321363. doi: 10.1101/2025.02.03.25321363.
- Individual participant dataSharing planned: Yes. Anonymized data may be shared at investigators discretion following submission of request, receipt of a data transfer agreement and local IRB approval
Related trials for Pediatric Obesity
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A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
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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.
Sarah C Armstrong, 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, 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 1 inclusion and 1 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 18 Jun 2021. 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?
The measure of abnormal metabolism using a sample biorepository (time frame: 5 years). 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 NCT02959034, which also lists 2 linked publications.
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 18 Jun 2021.