Hepatic SteatosisMANGONCT03587727
Hepatic Mitochondrial Function in Youth
An observational study of Hepatic Steatosis and Bariatric Surgery Candidate, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Assess the impact of bariatric surgery on hepatic energy metabolism and glucose and insulin dynamics in obese youth Read more about this study
- Who is it for?
- Ages 13 to 20 years
- Conditions the study is for
- Hepatic Steatosis, Bariatric Surgery Candidate, Adolescent Obesity
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2018to 21 Jun 2023
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Individuals age 13-20 years; Body Mass Index 35-55 m2/kg; Scheduled for Bariatric Surgery at Children's Hospital Colorado.
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anshutz Medical Campus/Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Hepatic Fat Content and Mitochondrial Flux in Obese Youth Before and After Bariatric Surgery
Assess the impact of bariatric surgery on hepatic energy metabolism and glucose and insulin dynamics in obese youth
Read the 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.
- Keywords
- bariatric surgery, hepatic mitochondria, insulin secretion
- Medical subject headings
- Fatty Liver, Pediatric Obesity, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Prior to bariatric surgery and 1 year post-bariatric surgery
Secondary outcomes (11)
Change in Insulin Sensitivity
Mixed meal tolerance test (MMTT): measured with SI. This is a measure of post-prandial (MMTT) insulin sensitivity as calculated with the Oral Minimal Model (OMM) using SAAM II Software. This software uses participant weight, glucose and insulin concentrations at various time points during the MMTT to calculate the participant insulin sensitivity. A positive Si value means an increase in insulin sensitivity.
Measured: Prior to bariatric surgery and 1 year post-bariatric surgery
Change in Peak Glucose
Mixed meal tolerance test (MMTT): Peak glucose concentration (mg/dL) during 4 hour MMTT with 16 time points.
Measured: Prior to bariatric surgery and 1 year post-bariatric surgery
Change in Minimum Glucose
Mixed meal tolerance test (MMTT): Minimum glucose concentration (mg/dL) during 4 hour MMTT with 16 time points.
Measured: Prior to bariatric surgery and 1 year post-bariatric surgery
Change in Peak Insulin
Mixed meal tolerance test (MMTT): Peak insulin concentration (uIU/mL) during 4 hour MMTT with 13 time points.
Measured: Prior to bariatric surgery and 1 year post-bariatric surgery
Change in Minimum Insulin
Mixed meal tolerance test (MMTT): Minimum insulin concentration (uIU/mL) during 4 hour MMTT with 13 time points.
Measured: Prior to bariatric surgery and 1 year post-bariatric surgery
Change in Peak C-peptide
Mixed meal tolerance test (MMTT): Peak c-peptide concentration (ng/mL) during 4 hour MMTT with 10 time points.
Measured: Prior to bariatric surgery and 1 year post-bariatric surgery
Change in Peak GLP-1
Mixed meal tolerance test (MMTT): Peak GLP-1 concentration (pmol/L) during 4 hour MMTT with 9 time points.
Measured: Prior to bariatric surgery and 1 year post-bariatric surgery
Change in Fasting Glucagon
Mixed meal tolerance test (MMT): Fasting glucagon concentration (pg/mL) at the beginning of a 4 hour MMTT 1 year post bariatric surgery minus prior to surgery. A negative value means there was a decrease in fasting glucagon concentrations one year post-bariatric surgery.
Measured: Prior to bariatric surgery and 1 year post-bariatric surgery
Change in Liver Stiffness Per MRI
Change from baseline in degree of hepatic stiffness, measured with Magnetic Resonance elastography (MRE).
Measured: Prior to bariatric surgery and 1 year post-bariatric surgery
Mitochondrial Function in the Liver Assessed by Oroboros
L/E Coupling Control Ratio: Maximal respiratory capacity was examined in permeabilized hepatic tissue from adolescents using pyruvate (carbohydrate) and palmitoylcarnitine (lipid) as a substrate. Respiratory capacity was normalized to hepatic tissue wet weight. Coupling control ratio (L/E) was calculated as oxygen flux in leak (oligomyocin) divided by ET capacity (FCCP) with a maximum coupling of 1.0.
Measured: At the time of surgery
Hepatic Steatosis Score Via Tissue Biopsy
NAFLD (non-alcoholic fatty liver disease) Activity Score (NAS) determined via liver tissue biopsy and graded by a pathologist. The NAS can range from 0 to 8 and is calculated by the sum of scores of steatosis (0-3), lobular inflammation (0-3) and hepatocyte ballooning (0-2). A higher number represent a worse outcome.
Measured: At the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start20 Nov 2018
- Primary completion21 Jun 2023
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatic SteatosisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melanie Cree-Green, MD, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587727
- Sponsor's protocol ID
- 18-0479
- Acronym
- MANGO
- Status last verified
- Sep 2025
- First submitted
- 14 Jun 2018
- Last updated
- 10 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No