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Clinical Trial Summary

The purpose of the study is to re-examine body composition, respiratory function, exercise tolerance, and dyspnea on exertion (DOE) in children with obesity (CWO) and children without obesity (CWOO) who were originally studied as 8-12-year-olds between 2016-2023 (i.e., originally Tanner score ≤ 3; 90 participants; 26 CWOO & 64 CWO). Additionally, the investigators will study the effects of weight loss on body composition, respiratory function, exercise tolerance, and DOE in CWO.


Clinical Trial Description

The prevalence of childhood obesity increases with age (20.7% aged 6-11 & 22.2% aged 12-19; NHANES 2017-2020). CWO, compared with CWOO, are more likely to have chronic health conditions. Results from the investigator's prior grant (HL136643) show that over one year, CWO can add four times as much fat weight as CWOO. However, it is unknown if this rate of increase in fat weight continues into adolescence and early adulthood, and whether respiratory function, exercise tolerance, or DOE are progressively worsened by increasing obesity. Furthermore, there could be a sex difference in the effects of obesity, given the different growth characteristics for boys and girls. It is also unknown if weight loss can reverse the trajectory of lifelong obesity. The investigator's long-term objective is to investigate the effects of 6 years of aging on body composition, respiratory function, exercise tolerance, and DOE in CWO and CWOO, and the effects of weight loss on body composition, respiratory function, exercise tolerance, and DOE in CWO. Specific Aims: The investigators will test the following hypotheses in CWO and CWOO after 6 years of aging: Aim 1) CWO originally studied at 8-12 years old will demonstrate a greater increase in fat weight and lower respiratory function (i.e., altered pulmonary function & breathing mechanics at rest) than in CWOO originally studied at 8-12 years old; Aim 2) CWO originally studied at 8-12 years old will demonstrate lower exercise tolerance measured during graded cycle ergometry (as evidenced by peak V • O2 in ml/min/kg, i.e., physical fitness) than in CWOO originally studied at 8-12 years old, but not lower cardiorespiratory fitness (as evidenced by peak V • O2 in % of predicted based on ideal body wt., i.e. cardiorespiratory fitness); Aim 3) CWO originally studied at 8-12 years old will demonstrate greater DOE as evidenced by increased ratings of perceived breathlessness during constant load exercise cycling than in CWOO originally studied at 8-12 years old; and Aim 4) Weight loss program offered by Children's Medical Center in Dallas. Once subjects have completed a 6 month weight loss program, the investigators will assess for body composition (decrease fat weight), respiratory function, exercise tolerance, and DOE in CWO. The investigator's long-term objective is to investigate the effects of 6 years of aging on body composition, respiratory function, exercise tolerance, and DOE in CWO and CWOO, and the effects of weight loss on body composition, respiratory function, exercise tolerance, and DOE in CWO. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06447246
Study type Observational
Source University of Texas Southwestern Medical Center
Contact
Status Enrolling by invitation
Phase
Start date June 17, 2024
Completion date August 31, 2029

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