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临床试验/NCT03637855
NCT03637855已完成不适用

Optical Body Composition and Health Assessment (Shape Up! Adults) Study

University of Hawaii1 个研究点 分布在 1 个国家目标入组 696 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
696
试验地点
1
主要终点
Fasting insulin levels

研究概览

简要总结

Identify the unique associations of body shape to body composition indices in a population that represents the variance of sex, age, BMI, and ethnicity found in the US population.

Describe the precision and accuracy of 3DO scans to monitor change in body composition and metabolic health interventions.

Estimate the level of association of 3DO to common health indicators including metabolic risk factors (glucose, triglycerides, HDL-cholesterol, blood pressure, VAT, WC and strength) by gender, race, age, and BMI.

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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 their body composition from what is typical for their age, sex, ethnicity, and BMI.

排除标准

  • Participants will be excluded if they have any internal metal artifact (e.g. pacemakers, internal fixation, arthroplasty), amputation, physical impairment or previous fracture that would alter body composition assessment or are 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.

结局指标

主要结局

Fasting insulin levels

时间窗: 1 day

Measure fasting insulin levels

HUMAC NORM

时间窗: 1 day

Will measure isokinetic strength of knee and back to assess muscle function

Fat mass

时间窗: 1 day

Measure fat mass and percent fat (arms, legs, trunk, and total) using Dual energy X-ray absorptiometry (DXA) data

Lean mass

时间窗: 1 day

Measure lean mass (arms, legs, trunk, and total) using Dual energy X-ray absorptiometry (DXA) data

Bone mass

时间窗: 1 day

Measure bone mass (arms, legs, lumbar spine, and total) and Bone Mineral Density (spine and total)

Waist to Hip ratio (WHR) from manual tape measurement

时间窗: 1 day

Manual physical anthropometry of waist and hip circumferences

Automatic 3D optical (3DO) scan measurement

时间窗: 1 day

Automated 3DO measurements generate the following: 476 girth, length, and volume measurements across the whole body.

Jamar hydraulic hand dynamometer

时间窗: 1 day

Will measure grip strength to assess muscle function

Fasting glucose levels

时间窗: 1 day

Measure fasting glucose levels

Fasting HbA1c levels

时间窗: 1 day

Measure fasting HbA1c levels

Fasting cholesterol levels

时间窗: 1 day

Measure fasting cholesterol levels

Fasting triglycerides levels

时间窗: 1 day

Measure fasting triglycerides levels

次要结局

未报告次要终点

研究者

发起方
University of Hawaii
申办方类型
Other
责任方
Sponsor

研究点 (1)

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