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Pediatric Metabolism and Microbiome Repository (PMMR)

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ClinicalTrials.gov Identifier: NCT02959034
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : January 31, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Duke University

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.

Condition or disease
Pediatric Obesity

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.


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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Pediatric Metabolism and Microbiome Repository
Study Start Date : September 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Group/Cohort
BMI > 95%
No Intervention
Healthy Weight Siblings
Control
Healthy Weight Unrelated
Control



Primary Outcome Measures :
  1. The measure of abnormal metabolism using a sample biorepository [ Time Frame: 5 years ]
    measures of metabolomics using a sample biorepository


Biospecimen Retention:   Samples With DNA

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.



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Ages Eligible for Study:   10 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959034


Contacts
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Contact: Janet Wootton, RN RSCN CRC 919 668 4809 janet.wootton@duke.edu
Contact: Cameron Catherine 919 620 5303 Cameron.catherine@duke.edu

Locations
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United States, North Carolina
Duke University Health System Recruiting
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Sarah C Armstrong, MD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02959034     History of Changes
Other Study ID Numbers: Pro00074547
1R24DK110492-01 ( U.S. NIH Grant/Contract )
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized data may be shared at investigators discretion following submission of request, receipt of a data transfer agreement and local IRB approval
Time Frame: Data will be available by December 31 2021
Access Criteria: Anonymized data may be shared as investigators discretion following submission of request, receipt of a data transfer agreement and local IRB approval
Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms