Expired Study
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Little Rock, Arkansas 72202


Purpose:

The purpose of the study is to determine energy expenditure and fat oxidation in 2 year old children.


Criteria:

Inclusion Criteria: - 1.5-2.5 years of age - Mother is a participant of the Glowing study (NCT01131117) - Healthy without taking medication that can affect study outcomes, as determined by the PI Exclusion Criteria: - None listed


Study is Available At:


Original ID:

203770


NCT ID:

NCT02414867


Secondary ID:


Study Acronym:


Brief Title:

Total Energy Expenditure and Fat Oxidation in 2 Year Old Children


Official Title:

Total Energy Expenditure and Fat Oxidation in 2 Year Old Children


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

2 Years


Maximum Age:

2 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Arkansas Children's Hospital Research Institute


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

16


Enrollment Type:

Actual


Study Dates

Start Date:February 2015
Completion Date:December 2017
Completion Type:Actual
Primary Completion Date:December 2017
Primary Completion Type:Actual
Verification Date:October 2019
Last Changed Date:October 7, 2019
First Received Date:April 8, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:To determine total energy expenditure in 2 year old children
Time Frame:15 days
Safety Issues:False
Description:Doubly labeled water is administered to 2 year old children and urine is collected at different time points.
Outcome Type:Primary Outcome
Measure:To determine fat oxidation in 2 year old children
Time Frame:2-6 hours
Safety Issues:False
Description:Deuterated palmitate is administered and urine is collected at different time points.

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:2
Description:Overweight/Obese mothers
Study Arm Type:Other
Arm Name:1
Description:Normal weight mothers

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Arkansas Children's Hospital Research Institute

Samples and Retentions

Sample Retention:Samples Without DNA
Description: Urine collected
Study Population: 120 toddlers born from mothers of the Glowing study (NCT01131117)
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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