Trial · NCT03467217
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Serum Alanine Aminotransferase (ALT) From Baseline. | Baseline and 24 weeks | Change ALT value in U/L (24 weeks minus baseline). A negative score indicates improvement. |
| Secondary | Change in Gamma-glutamyl Transpeptidase (GGT) Compared to Baseline | Baseline and 24 weeks | Change from baseline in gamma-glutamyl transpeptidase (GGT), measured in U/L. |
| Secondary | Change in Serum Aspartate Aminotransferase AST at 24 Weeks Compared to Baseline AST | Baseline and 24 weeks | Change from baseline in serum aspartate aminotransferase, measured in U/L. |
| Secondary | Relative Change in Serum Alanine Aminotransferase (ALT) Compared to Baseline ALT | Baseline and 24 weeks | Relative change from baseline in serum ALT, measured in percentage of change. |
| Secondary | Change in ALT at 12 Weeks Compared to Baseline ALT | Baseline and 12 weeks | Change from baseline in ALT at 12 weeks, measured in U/L. |
| Secondary | Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Compared to Baseline. | Baseline and 24 weeks | Homeostasis Model Assessment of Insulin Resistance Index (HOMA-IR) measures insulin resistance, calculated by fasting insulin (umol/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance. |
| Secondary | Change in Weight at 24 Weeks Compared to Baseline | Baseline and 24 weeks | Change from baseline in weight, measured in kg. |
| Secondary | Change in Body Mass Index (BMI) at 24 Weeks Compared to Baseline. | Baseline and 24 weeks | Change from baseline in BMI, measured in kg/m\^2. |
| Secondary | Change in Waist Circumference at 24 Weeks Compared to Baseline | Baseline and 24 weeks | Change from baseline in waist circumference, measured in centimeters. |
| Secondary | Change in Waist-to-hip Ratio at 24 Weeks Compared to Baseline | Baseline and 24 weeks | Change from baseline in waist-to-hip ratio, measured as the circumference of the waist in centimeters divided by the circumference of the hips in centimeters. |
| Secondary | Change in Pediatric Quality of Life Inventory (PedsQOL) Physical Health Score at 24 Weeks Compared to Baseline | Baseline and 24 weeks | Pediatric Quality of Life Inventory (PedsQOL) version 4.0 is composed of 23 items comprising 4 dimensions: Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. Scores are transformed on a scale from 0 to 100, with higher scores indicating better health-related quality of life. Physical Health Summary Score =Physical Functioning Scale Score. The outcome is 24-week change from baseline in PedsQOL Physical Health Score, where higher values indicate improvement in quality of life. |
| Secondary | Frequency of Adverse Events Over 24 Weeks | Baseline and 24 weeks | Numbers of adverse events reported over 24 weeks. |
| Secondary | Change in Total Cholesterol at 24 Weeks Compared to Baseline | Baseline and 24 weeks | Change from baseline in total cholesterol, measured in mg/dL |
| Secondary | Change in Triglycerides at 24 Weeks Compared to Baseline | Baseline and 24 weeks | Change from baseline in triglycerides, measured in mg/dL |
| Secondary | Change in HDL Cholesterol at 24 Weeks Compared to Baseline | Baseline and 24 weeks | Change from baseline in HDL cholesterol, measured in mg/dL |
| Secondary | Change in LDL Cholesterol at 24 Weeks Compared to Baseline | Baseline and 24 weeks | Change from baseline in LDL cholesterol, measured in mg/dL |
| Secondary | Change in Pediatric Quality of Life Inventory (PedsQOL) Psychosocial Health Score at 24 Weeks Compared to Baseline | Baseline and 24 weeks | Pediatric Quality of Life Inventory (PedsQOL) version 4.0 is composed of 23 items comprising 4 dimensions: Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. Scores are transformed on a scale from 0 to 100, with higher scores indicating better health-related quality of life. Psychosocial Health Summary Score = Sum of items over the number of items answered in the Emotional, Social, and School Functioning Scales. The outcome is 24-week change from baseline in PedsQOL Psychosocial Health Score, where higher values indicate improvement in quality of life. |
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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GET https://conductscience.org/api/trials/v1/NCT03467217/registered