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| ID | Type | Description | Link |
|---|---|---|---|
| K01DK119545 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | This is a cross-sectional study; no intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy males and females.
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| Name | Affiliation | Role |
|---|---|---|
| Robin P Shook, PhD | Children's Mercy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Kansas City | Kansas City | Missouri | 64108 | United States |
Aggregated results will be shared
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. No intervention: This is a cross-sectional study; no intervention |
| FG001 | 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. No intervention: This is a cross-sectional study; no intervention |
| FG002 | 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. No intervention: This is a cross-sectional study; no intervention |
| FG003 | 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. No intervention: This is a cross-sectional study; no intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. No intervention: This is a cross-sectional study; no intervention |
| BG001 | Normal Weight, Sedentary |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale*min | Baseline |
|
Baseline
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. No intervention: This is a cross-sectional study; no intervention |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extravasation of IV | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robin Shook, PhD | Children's Mercy Kansas City | (816) 234-9443 | rpshook@cmh.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 26, 2023 | Dec 11, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D008659 | Metabolic Diseases |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Male and female adolescents (age 14-17 years), BMI percentile >=5th to <75th for age/sex, <60 min/day of moderate/vigorous physical activity. No intervention: This is a cross-sectional study; no intervention |
| BG002 | 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. No intervention: This is a cross-sectional study; no intervention |
| BG003 | 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. No intervention: This is a cross-sectional study; no intervention |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | 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. No intervention: This is a cross-sectional study; no intervention |
| OG002 | 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. No intervention: This is a cross-sectional study; no intervention |
| OG003 | 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. No intervention: This is a cross-sectional study; no intervention |
|
|
| Primary | Appetite- Objective | The investigators will measure objective appetite responses using plasma ghrelin following a fixed-calorie meal. | Plasma ghrelin values were not assessed. Blood samples needed for assessment were not obtained due to lack of staff. Samples will not be collected in the future. | Posted | 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. Hunger score on a scale*min adjusted for glucose infusion rate (mL/kgFFM/min) and sex | Posted | Mean | Standard Deviation | score on a scale*min | Baseline |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 2 |
| 13 |
| EG001 | 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. No intervention: This is a cross-sectional study; no intervention | 0 | 11 | 0 | 11 | 2 | 11 |
| EG002 | 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. No intervention: This is a cross-sectional study; no intervention | 0 | 12 | 0 | 12 | 2 | 12 |
| EG003 | 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. No intervention: This is a cross-sectional study; no intervention | 0 | 10 | 0 | 10 | 1 | 10 |
| Lightheadedness during IV placement | Vascular disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |