Pediatric Metabolism and Microbiome Repository

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02959034

Acronym

PMMR

Enrollment

486

Registered

2016-11-08

Start date

2016-09-30

Completion date

2021-01-13

Last updated

2021-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Obesity

Brief 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.

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

10 Years to 23 Years

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

* Pregnant females.

Design outcomes

Primary

Measure	Time frame	Description
The measure of abnormal metabolism using a sample biorepository	5 years	measures of metabolomics using a sample biorepository

Countries

United States

Outcome results