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Enrolling by Invitation

NCT Number: NCT06447246

Respiratory Effects of Obesity in Children: Longitudinal Consequences After 6 Years of Aging

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).

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Key information

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for Exercise and Environmental Medicine, UT Southwestern and Texas Health Presbyterian Hospital Dallas

Dallas, Texas, 75231, United States

About this study

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.

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.

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The participants originally studied as 8-12-year-olds between 2016-2023 as part of the investigator's R01 HL136643.

Exclusion criteria

  • Children not able to follow directions, adequately perform procedures (e.g., pulmonary function tests), or keep appointments (e.g., no shows for testing).
  • If a child developed an abnormal ECG, showed other signs of clinical exercise intolerance, or signs of cardiovascular/lung disease during the exercise test, testing was terminated, and the child was referred to their personal physician for further evaluation.
  • Women who are pregnant or could possibly be pregnant (i.e. not using approved birth control measures and sexually active) will be excluded because of changes in body size during pregnancy and because unforeseeable risks to the fetus.
  • Presence of significant disease defined as a disease which in the opinion of the investigator may put the subject at risk because of participation in the study or a disease that may influence the results of the study or the subject's ability to participate in the study.
  • Patients who are non-English speaking will be excluded from the study because the tests performed are very effort dependent, detailed and require technical communication between the staff and the patient. The investigators feel that a translator would not be able to translate the technical terms fast enough to instruct the patient in the testing.

Treatment and study plan

Primary outcomes

  1. Pulmonary Function: Lung Volumes

    Time frame: Change from Baseline in differences between nonobese and obese children. Outcome measures will be assessed within 48-72 hours after completion of each study.

    Pulmonary function is comprised of several physiological variables but this study will primarily measure Lung Volume: FRC (liters) and TLC (liters)

  2. Exercise Tolerance - Peak VO2

    Time frame: Change from Baseline in differences between nonobese and obese children. Outcome measures will be assessed within 48-72 hours after completion of each study.

    Exercise Tolerances is represented by several physiological variables but the primary variable is Maximal oxygen uptake (L/min and percent predicted)

  3. Dyspnea on Exertion

    Time frame: Change from Baseline in differences between nonobese and obese children. Outcome measures will be assessed within 48-72 hours after completion of each study.

    Dyspnea on Exertion is represented using the Borg Scale which provides Ratings of Perceived Breathlessness (RPB) during constant load exercise cycling. The Borg Scale measures from 0-10, where 0 = no breathlessness and 10 = maximal breathlessness.

Other outcomes

  1. Pulmonary Function: Spirometry

    Time frame: Change from Baseline in differences between nonobese and obese children. Outcome measures will be assessed within 48-72 hours after completion of each study.

    Spirometry includes: Forced vital capacity (% predicted), Forced Expiratory Volume in 1 second (FEV1) (% predicted), FEV1/FVC (% predicted), and peak flow (% predicted.)

  2. Pulmonary Function: Diffusing Capacity

    Time frame: Change from Baseline in differences between nonobese and obese children. Outcome measures will be assessed within 48-72 hours after completion of each study.

    Diffusing Capacity: Diffusing capacity of lung for carbon monoxide(DLco) (ml/mmHg/min)

  3. Exercise Tolerance: Work Rate

    Time frame: Change from Baseline in differences between nonobese and obese children. Outcome measures will be assessed within 48-72 hours after completion of each study.

    Associated variables such as work rate (W)

  4. Exercise Tolerance: Minute Ventilation

    Time frame: Change from Baseline in differences between nonobese and obese children. Outcome measures will be assessed within 48-72 hours after completion of each study..

    Associated variables such as pulmonary ventilation (L/min)

  5. Exercise Tolerance: Operational Lung Volumes

    Time frame: Change from Baseline in differences between nonobese and obese children. Outcome measures will be assessed within 48-72 hours after completion of each study.

    Associated variables such as operational lung volumes (EELV and EILV as a % of TLC)

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jun 7, 2024
Registry last updated
Sep 5, 2025

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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