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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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)
Show all 12Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Fat Content and Mitochondrial Flux in Obese Youth Before and After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03587727
- Acronym / sponsor ID
- MANGO / 18-0479
- Keywords
- bariatric surgery, hepatic mitochondria, insulin secretion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 16 Jul 2018 (actual)
- Results
- Posted 10 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Percentage of Liver Fat Per MRI
Time frame: Prior to bariatric surgery and 1 year post-bariatric surgery
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.
Change in %Direct TG-Glycerol Appearance
Time frame: Prior to bariatric surgery and 1 year post-bariatric surgery
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.
11 secondary outcomes
Change in Insulin Sensitivity
Time frame: Prior to bariatric surgery and 1 year post-bariatric surgery
Change in Peak Glucose
Time frame: Prior to bariatric surgery and 1 year post-bariatric surgery
Change in Minimum Glucose
Time frame: Prior to bariatric surgery and 1 year post-bariatric surgery
Change in Peak Insulin
Time frame: Prior to bariatric surgery and 1 year post-bariatric surgery
Change in Minimum Insulin
Time frame: Prior to bariatric surgery and 1 year post-bariatric surgery
Change in Peak C-peptide
Time frame: Prior to bariatric surgery and 1 year post-bariatric surgery
Change in Peak GLP-1
Time frame: Prior to bariatric surgery and 1 year post-bariatric surgery
Change in Fasting Glucagon
Time frame: Prior to bariatric surgery and 1 year post-bariatric surgery
Change in Liver Stiffness Per MRI
Time frame: Prior to bariatric surgery and 1 year post-bariatric surgery
Mitochondrial Function in the Liver Assessed by Oroboros
Time frame: At the time of surgery
Hepatic Steatosis Score Via Tissue Biopsy
Time frame: At the time of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Cree-Green, MD, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Steatosis and Bariatric Surgery Candidate, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percentage of Liver Fat Per MRI (time frame: Prior to bariatric surgery and 1 year post-bariatric surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.