Clinical trial NCT03587727: Hepatic Mitochondrial Function in Youth
Official title: Hepatic Fat Content and Mitochondrial Flux in Obese Youth Before and After Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hepatic Steatosis
Bariatric Surgery Candidate
Adolescent Obesity
Obesity
Keywords: bariatric surgery
hepatic mitochondria
insulin secretion
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 19
Sex: ALL
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Detailed description: A metabolic study that will be performed prior to and 12 months following bariatric surgery. The study will include 31-phosphorus magnetic resonance spectroscopy to measure phosphate concentrations in the liver; a 4 hour mixed meal tolerance test, an intravenous arginine test, Abdominal Magnetic Resonance Imaging (MRI) for visceral and hepatic fat, Magnetic Resonance (MR) Elastography of the liver, indirect calorimetry, body composition assessment with Bodpod, serum metabolomics and hepatic tissue mitochondrial measures from the time of surgery only.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Use of medications known to affect insulin sensitivity: oral glucocorticoids within 10; days, atypical antipsychotics, immunosuppressant agents, HIV medications.
2. Infectious hepatitis
3. Alcohol abuse
4. Mitochondrial disease
5. Type 2 diabetes
6. Medications that affect hepatic outcomes (e.g. PPAR-γ or PPAR-α, metformin)
7. Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study.
8. Severe illness requiring hospitalization within 60 days
9. Diabetes, defined as Hemoglobin A1C \> 6.4%
10. Anemia, defined as Hemoglobin \< 10 mg/dL
11. Diagnosed major psychiatric or developmental disorder limiting informed consent
12. Implanted metal devices that are not compatible with MRI

Primary outcomes:
measure: Percent Change in Liver Fat per MRI
timeFrame: Prior to bariatric surgery and 1 year post-bariatric surgery
measure: Change in %Direct TG-Glycerol Appearance
timeFrame: Prior to bariatric surgery and 1 year post-bariatric surgery
Secondary outcomes:
measure: Change in Insulin Sensitivity
timeFrame: Prior to bariatric surgery and 1 year post-bariatric surgery
measure: Change in Peak Glucose
timeFrame: Prior to bariatric surgery and 1 year post-bariatric surgery
measure: Change in Minimum Glucose
timeFrame: Prior to bariatric surgery and 1 year post-bariatric surgery
measure: Change in Peak Insulin
timeFrame: Prior to bariatric surgery and 1 year post-bariatric surgery
measure: Change in Minimum Insulin
timeFrame: Prior to bariatric surgery and 1 year post-bariatric surgery
measure: Change in Peak C-peptide
timeFrame: Prior to bariatric surgery and 1 year post-bariatric surgery
measure: Change in Peak GLP-1
timeFrame: Prior to bariatric surgery and 1 year post-bariatric surgery
measure: Change in Fasting Glucagon
timeFrame: At time of surgery
measure: Change in Liver Stiffness per MRI
timeFrame: Prior to bariatric surgery and 1 year post-bariatric surgery
measure: Mitochondrial Function in the Liver Assessed by Oroboros
timeFrame: At the time of surgery
measure: Baseline Hepatic Steatosis Score via Tissue
timeFrame: At the time of surgery
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anshutz Medical Campus/Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Melanie Cree-Green, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: