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Tumor-Derived FGF19
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Breast Cancer, Breast Diseases
Orlando, Florida, United States
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Completed
NCT Number: NCT03706612
Shape Up! Kids Study
Identify the unique associations of body shape to body composition and bone density indices in a pediatric population that represents the variance of sex, age, BMI-Z, and ethnicity found in the US population.
Describe the precision and accuracy of optical scans to monitor change in body composition, bone density and metabolic health interventions.
Estimate the level of association of optical to common health indicators including metabolic risk factors (glucose, triglycerides, HDL-cholesterol, blood pressure, VAT, WC and strength) by gender, race, age, and BMI-Z.
Investigate holistic, high-resolution descriptors of 3D body shape as direct predictors of body composition and metabolic risk using statistical shape models and Latent Class Analysis.
Completed
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Notify MeKey information
Conditions
Age range
5 year–17 year
Sex eligibility
All sexes
Study type
Observational
Primary location
University of California, San Francisco, San Francisco, California, United States
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Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Healthy participants will be included in the study if they have a self-reported ability to:
- walk one-quarter of a mile and climb 10 steps without difficulty,
- perform activities of daily living (ADLs) without difficulty, and
- have no life-threatening conditions or diseases that would alter body composition from what is typical for age, sex, ethnicity, and BMI.
Exclusion criteria
- any internal metal artifact (e.g. pacemakers, internal fixation, arthroplasty), amputation, physical impairment or previous fracture that would alter body composition assessment
- Pregnant or breastfeeding. (All premenopausal females will be asked for a spot urine sample for pregnancy test prior to participation. Those unwilling to comply with this will not be included.
Treatment and study plan
Primary outcomes
-
Fat mass by DXA
Time frame: 1 day
Measure fat mass and percent fat (arms, legs, trunk, and total) using Dual energy X-ray absorptiometry (DXA) data
-
Lean mass by DXA
Time frame: 1 day
Measure lean mass (arms, legs, trunk, and total) using Dual energy X-ray absorptiometry (DXA) data
-
Bone mass by DXA
Time frame: 1 day
Measure bone mass (arms, legs, lumbar spine, and total) and Bone Mineral Density (spine and total) using Dual energy X-ray absorptiometry (DXA) data
-
Fat mass by MRI
Time frame: 1 day
Measure fat mass and percent fat (arms, legs, trunk, visceral, and total) using MRI data
-
Lean mass by MRI
Time frame: 1 day
Measure lean mass (arms, legs, trunk, and total) using MRI data
-
Waist to Hip ratio (WHR) from manual tape measurement
Time frame: 1 day
Manual physical anthropometry of waist and hip circumferences
-
Automatic 3D optical (3DO) scan measurement
Time frame: 1 day
Automated 3DO measurement generated across the body
-
Hand-grip strength
Time frame: 1 day
Measured by using a hand-grip dynamometer (JAMAR) as a measure of strength and physical capacity.
-
Isokinetic peak torque
Time frame: 1 day
Measure the peak torque value (FT-LBS) generated during isokinetic knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device
-
Isometric peak torque
Time frame: 1 day
Measure the peak torque value (FT-LBS) generated during isometric knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device
-
Fasting glucose levels
Time frame: 1 day
Measure fasting glucose levels
-
Fasting HbA1c levels
Time frame: 1 day
Measure fasting HbA1c levels
-
Fasting insulin levels
Time frame: 1 day
Measure fasting insulin levels
-
Fasting cholesterol levels
Time frame: 1 day
Measure fasting cholesterol levels
-
Fasting triglycerides levels
Time frame: 1 day
Measure fasting triglycerides levels
Secondary outcomes
-
Fat loss
Time frame: 24 weeks
Measure changes in fat mass during intervention using DXA data.
-
Changes in lean mass
Time frame: 24 weeks
Measure changes in lean mass (arms, legs, trunk, and total) during intervention using DXA data.
-
Changes in WHR
Time frame: 24 weeks
Measure changes in WHR during intervention
-
Changes in automatic 3DO scan measurement
Time frame: 24 weeks
Changes of automated 3DO measurements during intervention
-
Changes in isokinetic peak torque
Time frame: 24 weeks
Measure the change in peak torque value generated during isokinetic knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device pre and post intervention.
-
Changes in isometric peak torque
Time frame: 24 weeks
Measure the change in peak torque value generated during isometric knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device pre and post intervention
-
Total Body Water
Time frame: 24 weeks
Measure total body water (L) provided by bioelectrical impedance analysis
-
Phase angle
Time frame: 24 weeks
Phase angle [PhA(°) = (reactance/electrical resistance) × (180°/Π)] will be measured in degrees using bioelectrical impedance analysis.
-
Percent body fat
Time frame: 24 weeks
Measure percent body fat provided by bioelectrical impedance analysis.
-
Body circumference from 2D imaging
Time frame: 24 weeks
A conventional digital camera will be used to capture 2D images of participants in a standardized pose. Body circumference will be estimated using these images.
-
Systolic and Diastolic blood pressure levels will be assessed
Time frame: 24 weeks
Manually measure systolic and diastolic blood pressure levels.
-
Diet History Questionnaire II
Time frame: 24 weeks
The Diet History Questionnaire II estimates the participants nutrition intake by asking the participant a series of questions
Sponsors and collaborators
Lead sponsor
University of Hawaii
Other
Collaborators
- Pennington Biomedical Research Center
- University of California, San Francisco
Registry information
Important dates
- Study start
- 2017
- Primary completion
- 2023
- Study completion
- 2023
- First posted
- Oct 16, 2018
- Registry last updated
- Jan 23, 2023
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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