Hepatic Mitochondrial Function in Youth

NCT03587727 | Completed Results

• 1 other identifier: 18-0479
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Assess the impact of bariatric surgery on hepatic energy metabolism and glucose and insulin dynamics in obese youth

Conditions

Hepatic Steatosis; Bariatric Surgery Candidate; Adolescent Obesity; Obesity

Keywords

bariatric surgery; hepatic mitochondria; insulin secretion

Outcome Measures

Primary Outcomes (2)

• Change in Percentage of Liver Fat Per MRI

  Percentage of liver fat at 1 year post-bariatric surgery minus percentage of liver fat prior to bariatric surgery. Liver fat measured with MRI and calculated via the Dixon method as the proton density hepatic fat. A negative value means a decrease in liver fat after bariatric surgery.

  Prior to bariatric surgery and 1 year post-bariatric surgery

• Change in %Direct TG-Glycerol Appearance

  Change in %TG-Glycerol appearance from a labeled glycerol drink via direct pathway. TCA substrate cycling assessed via change in fractional direct glycerol carbon contributions to newly synthesized triglycerides using a U-13C glycerol tracer drink. A higher direct percentage is beneficial, indicating decreased oxidative stress resulting from excess glycerol metabolism through the TCA cycle.

  Prior to bariatric surgery and 1 year post-bariatric surgery

Secondary Outcomes (11)

• Change in Insulin Sensitivity

  Prior to bariatric surgery and 1 year post-bariatric surgery

• Change in Peak Glucose

  Prior to bariatric surgery and 1 year post-bariatric surgery

• Change in Minimum Glucose

  Prior to bariatric surgery and 1 year post-bariatric surgery

• Change in Peak Insulin

  Prior to bariatric surgery and 1 year post-bariatric surgery

• Change in Minimum Insulin

  Prior to bariatric surgery and 1 year post-bariatric surgery

Eligibility Criteria

• Age: 13 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals age 13-20 years; Body Mass Index 35-55 m2/kg; Scheduled for Bariatric Surgery at Children's Hospital Colorado.

You may qualify if:

• Obese youth ages 13-20 years, scheduled for bariatric surgery at Children's Hospital Colorado
• BMI 35-55 m2/kg
• Maximal body circumference \<200 cm

You may not qualify if:

• Use of medications known to affect insulin sensitivity: oral glucocorticoids within 10; days, atypical antipsychotics, immunosuppressant agents, HIV medications.
• Infectious hepatitis
• Alcohol abuse
• Mitochondrial disease
• Type 2 diabetes
• Medications that affect hepatic outcomes (e.g. PPAR-γ or PPAR-α, metformin)
• Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study.
• Severe illness requiring hospitalization within 60 days
• Diabetes, defined as Hemoglobin A1C \> 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anshutz Medical Campus/Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

With participant consent, samples will be kept and may be used in future research to learn more about NAFLD and risk for type 2 diabetes.

MeSH Terms

Conditions

Fatty Liver; Pediatric Obesity; Obesity

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Limited by small sample size due to participant withdraw.

Results Point of Contact

• Title: Yesenia Garcia Reyes
• Organization: University of Colorado

Yesenia.GarciaReyes@childrenscolorado.org

720-777-6984

Study Officials

• Melanie Cree-Green, MD, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: July 16, 2018
• Study Start: November 20, 2018
• Primary Completion: June 21, 2023
• Study Completion: June 21, 2023
• Last Updated: October 10, 2025
• Results First Posted: October 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)