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

Childhood Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06447246
• Other study ID #: STU-2024-0444
• Status: Enrolling by invitation
• 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
• 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

Other:
• Weight Loss
The investigators are not studying the effectiveness a weight loss intervention, nor the rate of weight loss, nor any specific AOM. Participation in the weight loss program will be optional. The CWO who elect to participate in the weight loss option will receive standard of care by co-investigator Dr. Barlow with their weight loss program.

Locations

Country	Name	City	State
United States	Institute for Exercise and Environmental Medicine, UT Southwestern and Texas Health Presbyterian Hospital Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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