Childhood Obesity Clinical Trial
Official title:
Respiratory Effects of Obesity in Children: Longitudinal Consequences After 6 Years of Aging
Verified date | June 2024 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 90 |
Est. completion date | August 31, 2029 |
Est. primary completion date | August 31, 2029 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 14 Years to 18 Years |
Eligibility | Inclusion Criteria: The participants originally studied as 8-12-year-olds between 2016-2023 as part of the investigator's R01 HL136643. Exclusion Criteria: 1. Children not able to follow directions, adequately perform procedures (e.g., pulmonary function tests), or keep appointments (e.g., no shows for testing). 2. 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. 3. 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. 4. 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. 5. 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. |
Country | Name | City | State |
---|---|---|---|
United States | Institute for Exercise and Environmental Medicine, UT Southwestern and Texas Health Presbyterian Hospital Dallas | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pulmonary Function: Spirometry | Spirometry includes: Forced vital capacity (% predicted), Forced Expiratory Volume in 1 second (FEV1) (% predicted), FEV1/FVC (% predicted), and peak flow (% predicted.) | Change from Baseline in differences between nonobese, obese children and obese children with weight loss at 9 months | |
Other | Pulmonary Function: Diffusing Capacity | Diffusing Capacity: Diffusing capacity of lung for carbon monoxide(DLco) (ml/mmHg/min) | hange from Baseline in differences between nonobese, obese children and obese children with weight loss at 9 months | |
Other | Exercise Tolerance: Work Rate | Associated variables such as work rate (W) | Change from Baseline in differences between nonobese, obese children and obese children with weight loss at 9 months | |
Other | Exercise Tolerance: Minute Ventilation | Associated variables such as pulmonary ventilation (L/min) | Change from Baseline in differences between nonobese, obese children and obese children with weight loss at 9 months | |
Other | Exercise Tolerance: Operational Lung Volumes | Associated variables such as operational lung volumes (EELV and EILV as a % of TLC) | Change from Baseline in differences between nonobese, obese children and obese children with weight loss at 9 months | |
Primary | Pulmonary Function: Lung Volumes | Pulmonary function is comprised of several physiological variables but this study will primarily measure Lung Volume: FRC (liters) and TLC (liters) | Change from Baseline in differences between nonobese, obese children and obese children with weight loss at 9 months | |
Primary | Exercise Tolerance - Peak VO2 | Exercise Tolerances is represented by several physiological variables but the primary variable is Maximal oxygen uptake (L/min and percent predicted) | Change from Baseline in differences between nonobese, obese children and obese children with weight loss at 9 months | |
Primary | Dyspnea on Exertion | 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. | Change from Baseline in differences between nonobese, obese children and obese children with weight loss at 9 months |
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