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Completed

NCT Number: NCT02959034

Pediatric Metabolism and Microbiome Repository

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.

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Key information

Conditions

Pediatric Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

10 year–23 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Health System

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The measure of abnormal metabolism using a sample biorepository

    Time frame: 5 years

    measures of metabolomics using a sample biorepository

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: PMMR

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Nov 8, 2016
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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