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NCT02959034 Clinical Trial

Pediatric Metabolism and Microbiome Repository

Pediatric Obesity Clinical Trial

— PMMR  

Official title:
Pediatric Metabolism and Microbiome Repository

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02959034
Other study ID # Pro00074547
Secondary ID 1R24DK110492-01
Status Completed
Phase
First received
Last updated
Start date September 2016
Est. completion date January 13, 2021

Study information
Verified date June 2021
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 486
Est. completion date January 13, 2021
Est. primary completion date January 13, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 23 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Duke University Health System Durham North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Duke University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The measure of abnormal metabolism using a sample biorepository measures of metabolomics using a sample biorepository 5 years
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