Pediatric Metabolism and Microbiome Repository | NCT02959034

Studies
Pediatric Metabolism and Microbiome Repository

NCT02959034

Sponsor

Duke University

Status

Completed

Last Update Posted

Jun 18, 2021Actual

Enrollment

486Actual

Phase

Not provided

Conditions

Pediatric Obesity

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R24DK110492-01	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Jan 13, 2021Actual

Completion Date

Jan 13, 2021Actual

First Submitted Date

Sep 29, 2016

First Submission Date that Met QC Criteria

Nov 7, 2016

First Posted Date

Nov 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2021

Last Update Posted Date

Jun 18, 2021Actual

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

486Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BMI > 95%		No Intervention
Healthy Weight Siblings		Control
Healthy Weight Unrelated		Control

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

23 Years

Standard Ages

ChildAdult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sarah C Armstrong, MD	Duke University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke University Health System		Durham	North Carolina	27710	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39974080	Derived	McCann 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.

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders