Activity, Adiposity, and Appetite in Adolescents 2

NCT04028921 | Completed Results DMC

• 2 other identifiers: STUDY00001808K01DK119545
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Metabolic Disease; Insulin Sensitivity

Outcome Measures

Primary Outcomes (3)

• Appetite- Subjective

  The investigators will measure subjective appetite ratings using visual analog scales related to hunger following a fixed-calorie meal: Hunger, Area Under the Curve (AUC) Hunger and palatability were assessed using self-rated visual analogue scales (Rogers, P. J., \& Blundell, J. E. (1993). Intense sweeteners and appetite. The American Journal of Clinical Nutrition, 58(1), 120-122.) Scale is 0-100, with 0 equaling 'I am not hungry at all' and 100 equaling 'I have never been more hungry'. Area under the curve (AUC) was calculated for appetite variables by calculating the area of the response as you would a trapezoid.

  Baseline

• Appetite- Objective

  The investigators will measure objective appetite responses using plasma ghrelin following a fixed-calorie meal.

  Baseline

• 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. Hunger score on a scale\*min adjusted for glucose infusion rate (mL/kgFFM/min) and sex

  Baseline

Study Arms (4)

Normal weight, active

Male and female adolescents (age 14-17 years), BMI percentile \>=5th to \<75th for age/sex, \>=60 min/day of moderate/vigorous physical activity.

Other: No intervention

Normal weight, sedentary

Male and female adolescents (age 14-17 years), BMI percentile \>=5th to \<75th for age/sex, \<60 min/day of moderate/vigorous physical activity.

Other: No intervention

Overweight/obese, active

Male and female adolescents (age 14-17 years), BMI percentile \>=85th to \<99th for age/sex, \>=60 min/day of moderate/vigorous physical activity.

Other: No intervention

Overweight/obese, sedentary

Male and female adolescents (age 14-17 years), BMI percentile \>=85th to \<99th for age/sex, \<60 min/day of moderate/vigorous physical activity.

Other: No intervention

Interventions

No intervention OTHER

This is a cross-sectional study; no intervention

Normal weight, active; Normal weight, sedentary; Overweight/obese, active; Overweight/obese, sedentary

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy males and females.

You may qualify if:

• Tanner Stage III-V
• Non-smoking
• Not currently involved in any other research study

You may not qualify if:

• 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)

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Obesity; Metabolic Diseases; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders

Results Point of Contact

• Title: Dr. Robin Shook, PhD
• Organization: Children's Mercy Kansas City

rpshook@cmh.edu

(816) 234-9443

Study Officials

• Robin P Shook, PhD

  Children's Mercy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 23, 2019
• Study Start: January 3, 2022
• Primary Completion: November 1, 2023
• Study Completion: June 30, 2024
• Last Updated: April 2, 2025
• Results First Posted: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)