Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT06447246 |
Other study ID # |
STU-2024-0444 |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
|
First received |
|
Last updated |
|
Start date |
June 17, 2024 |
Est. completion date |
August 31, 2029 |
Study information
Verified date |
June 2024 |
Source |
University of Texas Southwestern Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
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.
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.