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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04028921
Other study ID # STUDY00001808
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 3, 2022
Est. completion date June 30, 2024

Study information

Verified date January 2024
Source Children's Mercy Hospital Kansas City
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Our goal is to examine linkages between physical activity, appetite control, and energy metabolism in adolescents. The investigators will assess metabolic function and appetite control in male and female adolescents stratified by bodyweight and physical activity using across-sectional study design.


Description:

Childhood obesity is the most serious public health problem of the 21st century, given the prevalence, global reach, and widespread health, economic, and social consequences. While weight gain at the most basic level is due to a chronic energy surplus, there are a host of influences that act on the energy balance system that remain largely unknown. Thus, there is a critical need to identify previously unexamined factors that may influence the energy balance system in order to develop effective interventions for prevention and treatment. Our long-term goal is to quantify the dynamic relationships between various physiological and psychological components of the energy balance system. Our short-term goal is to examine linkages between physical activity, appetite control, and energy metabolism in adolescents. The status quo as it relates to appetite control is that body weight status and related peripheral signals are a key regulator of energy intake. In contrast to body weight playing a primary role in energy regulation, our working hypothesis is that high levels of regular moderate-to-vigorous physical activity (MVPA) result in a metabolic phenotype consisting of enhanced metabolic function and proper regulation of appetite, which prevents the development of obesity. The investigators have reported that adults with low levels of MVPA have dysregulated appetite control, evidenced by higher levels of energy intake and elevated levels of dietary disinhibition. Additionally, the investigators have observed that rats with low fitness possess dysregulated control of appetite and reduced hepatic fat oxidation compared to rats with high fitness. Based on these findings in adults and rodents, in addition to supportive work by others, the investigators hypothesize that low levels of MVPA create a metabolic phenotype, leading to dysregulated appetite control which predisposes individuals to weight gain. To test this hypothesis the investigators will perform a study focused on the links between physical activity and appetite. The investigators will assess metabolic function and appetite control in male and female adolescents stratified by bodyweight (normal vs overweight/obese) and physical activity (sedentary vs. active) using a 2 x 2 cross-sectional study design (N=44). The specific aim of the proposed study is: 1) To examine the association between physical activity and appetite control in adolescents, with metabolic function serving as a mediator. At the completion of the study, it is our expectation that the investigators will have described the independent effects of physical activity and body weight on energy metabolism and appetite in adolescents. This study will have a significant positive impact on the understanding of energy balance in adolescents, and will inform public health interventions that specifically target mechanisms associated with weight gain in youth.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 44
Est. completion date June 30, 2024
Est. primary completion date November 1, 2023
Accepts healthy volunteers
Gender All
Age group 14 Years to 17 Years
Eligibility Inclusion Criteria: - Tanner Stage III-V - Non-smoking - Not currently involved in any other research study Exclusion Criteria: - Restrained eater (>13) on the restraint section of the three-factor eating questionnaire; Current/past diagnosis of an eating disorder - Gave birth in the past 12 months or <6 months post-lactation. - Self-reported medical conditions (diabetes, Crohn's disease, etc.) that may affect adherence to the protocol or exercising safely or alter metabolism - Medications known to affect exercise performance or metabolism (e.g. thyroid medication, beta-blockers, or stimulants)

Study Design


Intervention

Other:
No intervention
This is a cross-sectional study; no intervention

Locations

Country Name City State
United States Children's Mercy Kansas City Kansas City Missouri

Sponsors (1)

Lead Sponsor Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Appetite- subjective The investigators will measure subjective appetite ratings using visual analog scales related to hunger following a fixed-calorie meal. Baseline
Primary Appetite- objective The investigators will measure objective appetite responses using plasma ghrelin following a fixed-calorie meal. Baseline
Primary Appetite- adjusted The investigators will measure objective and subjective appetite responses as described above adjusted by insulin sensitivity (glucose infusion rate, mg/kg/min) as assessed in the euglycemic hyperinsulinemic clamp technique. Baseline
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