N/A
N=20
Hepatic Mitochondrial Function in Youth
Hepatic Steatosis · Bariatric Surgery Candidate · Adolescent Obesity · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03587727 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Change in Percentage of Liver Fat Per MRI — -13.93 percentage of liver fat
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percentage of Liver Fat Per MRI |
-13.93 | — |
| PRIMARY Change in %Direct TG-Glycerol Appearance |
0.33 | — |
| SECONDARY Change in Insulin Sensitivity |
0.000552758 | — |
| SECONDARY Change in Peak Glucose |
11.5 | — |
| SECONDARY Change in Minimum Glucose |
-7 | — |
| SECONDARY Change in Peak Insulin |
28.333 | — |
| SECONDARY Change in Minimum Insulin |
-7.333 | — |
| SECONDARY Change in Peak C-peptide |
1.7 | — |
| SECONDARY Change in Peak GLP-1 |
-7.1117 | — |
| SECONDARY Change in Fasting Glucagon |
-41.333 | — |
| SECONDARY Change in Liver Stiffness Per MRI |
-0.234 | — |
| SECONDARY Mitochondrial Function in the Liver Assessed by Oroboros |
0.34; 0.50 | — |
| SECONDARY Hepatic Steatosis Score Via Tissue Biopsy |
3; 1; 3; 4; 3; 1 | — |
Summary
Assess the impact of bariatric surgery on hepatic energy metabolism and glucose and insulin dynamics in obese youth
Eligibility Criteria
Inclusion Criteria
- Obese youth ages 13-20 years, scheduled for bariatric surgery at Children's Hospital Colorado
- BMI 35-55 m2/kg
- Maximal body circumference 6.4%
- Anemia, defined as Hemoglobin < 10 mg/dL
- Diagnosed major psychiatric or developmental disorder limiting informed consent
- Implanted metal devices that are not compatible with MRI
Data sourced from ClinicalTrials.gov (NCT03587727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.