Trial · NCT06899178
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Body Mass Index (BMI) | 16 weeks | BMI will be calculated as kg/sq m. The sex appropriate CDC growth chart will be used to calculate BMI as a percent of the 95th percentile (BMI95). For patients \>20 years, the 20-year-old percentiles will be used. |
| Secondary | Resting Energy Expenditure (REE) | 16 weeks | Resting energy expenditure (REE) will be measured by indirect calorimetry after a minimum 1 hour of rest in the Clinical Research Center. Oxygen consumption and carbon dioxide production will be measured. The first 5-10 minutes of data will be discarded to allow participants to adjust to the metabolic cart. |
| Secondary | Healthy Eating Index (HEI) | 16 weeks | The VioScreen assessment provides a Healthy Eating Index (HEI) score to measure the quality of a person's diet. The HEI score ranges from 0 to 100, with higher scores indicating better eating habits. |
| Secondary | Hyperphagia Questionnaire (HQ) | 16 weeks | Hyperphagia will be assessed with the Hyperphagia Questionnaire (HQ) This is a 13-item questionnaire with each question answered on a 5-point scale. Two of the questions are qualitative. Full range is scored from 11 to 55. Higher score indicates greater hyperphagia. |
| Secondary | Hunger and Satiety Score | 16 weeks | Full range scored from 0 to 10 with higher score indicating greater hunger/satiety. |
| Secondary | Fasting Glucose Level | At week 0, week 16 and week 32. | A blood sugar test measures the amount of a sugar called glucose in a sample of blood. Fasting laboratory studies will be obtained at week 0, week 16 and week 32. |
| Secondary | Alanine Transaminase (ALT) Level | At week 0, week 16 and week 32. | The alanine transaminase (ALT) blood test measures the level of the enzyme ALT in the blood. ALT is an enzyme found in a high level in the liver. An enzyme is a protein that causes a specific chemical change in the body. Fasting laboratory studies will be obtained at week 0, week 16 and week 32. |
| Secondary | Fasting Insulin Level | At week 0, week 16 and week 32. | The insulin level in blood. Insulin is a hormone produced by beta cells in the pancreas. Fasting laboratory studies will be obtained at week 0, week 16 and week 32. |
| Secondary | Hemoglobin A1c | At week 0, week 16 and week 32. | A1C is a lab test that shows the average level of blood sugar (glucose) over the previous 3 months. It shows how well blood sugar is controlled to help prevent complications from diabetes. Fasting laboratory studies will be obtained at week 0, week 16 and week 32. |
| Secondary | Lipid Panel - Fasting LDL, HDL, Triglycerides | At week 0, week 16 and week 32. | A lipid profile is a blood test to measure different types of lipids: High-density lipoprotein cholesterol (HDL \[good\] cholesterol): HDL helps remove LDL from your blood. Low-density lipoprotein cholesterol (LDL \[bad\] cholesterol): LDL can build up in your blood vessels and increase your heart disease risk. Triglycerides: Your body makes some triglycerides. Triglycerides also come from the food you eat. Extra calories are turned into triglycerides and stored in fat cells for later use. Fasting laboratory studies will be obtained at week 0, week 16 and week 32. |
| Secondary | High Sensitivity C-Reactive Protein | At week 0, week 16 and week 32. | C-reactive protein (CRP) is produced by the liver. The level of CRP rises when there is inflammation in the body. It is one of a group of proteins, called acute phase reactants that go up in response to inflammation. The levels of acute phase reactants increase in response to certain inflammatory proteins called cytokines. These proteins are produced by white blood cells during inflammation. The CRP test is a general test to check for inflammation in the body. It is not a specific test. A high-sensitivity C-reactive protein (hs-CRP) is a more A more sensitive CRP test Fasting laboratory studies will be obtained at week 0, week 16 and week 32. |
| Secondary | The ASEBA Brief Problem Monitor | 16 weeks | The ASEBA Brief Problem Monitor (BPM) is a quick assessment tool designed to monitor and track a child's behavioral and emotional problems over time, particularly focusing on internalizing, externalizing, and attention issues. Range is 0 to 99.9th percentile |
| Secondary | Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist. | 16 weeks | This is an 18-item self-report questionnaire designed for individuals to assess their own symptoms of Attention Deficit Hyperactivity Disorder (ADHD) focusing on daily experiences related to attention, impulsivity, and hyperactivity. Total scale is scored 0-72 with higher score indicating more predictive of an ADHD diagnosis. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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