Trial Outcomes & Findings for Hepatic Mitochondrial Function in Youth (NCT NCT03587727)

NCT ID: NCT03587727

Last Updated: 2025-10-10

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 20 participants
• Primary outcome timeframe: Prior to bariatric surgery and 1 year post-bariatric surgery
• Results posted on: 2025-10-10

Participant Flow

Participant milestones

Measure	Teenagers 13-20 Years Old in Bariatric Surgery Program 13-20 year old male and female participants before and after bariatric surgery.
Overall Study STARTED	20
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	Teenagers 13-20 Years Old in Bariatric Surgery Program 13-20 year old male and female participants before and after bariatric surgery.
Overall Study 10 did not complete either of the pre-op MMTT or post-op MMTT.	10
Overall Study 4 completed the pre-op MMTT but did not complete the post-op MMTT.	4

Baseline Characteristics

Hepatic Mitochondrial Function in Youth

Baseline characteristics by cohort

Measure	Teenagers 13-20 Years Old in Bariatric Surgery Program n=20 Participants 13-20 year old male and female participants before and after bariatric surgery.
Age, Continuous	16.85 years STANDARD_DEVIATION 1.576 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Teenagers 13-20 Years Old in Bariatric Surgery Program n=6 Participants 13-20 year old male and female participants before and after bariatric surgery.
Change in Percentage of Liver Fat Per MRI	-13.93 percentage of liver fat Standard Deviation 12.89

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Teenagers 13-20 Years Old in Bariatric Surgery Program n=6 Participants 13-20 year old male and female participants before and after bariatric surgery.
Change in %Direct TG-Glycerol Appearance	0.33 change in percentage of Direct TG-Glycer Standard Deviation 3.204

SECONDARY outcome

Timeframe: Prior to bariatric surgery and 1 year post-bariatric surgery

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.

Outcome measures

Measure	Teenagers 13-20 Years Old in Bariatric Surgery Program n=6 Participants 13-20 year old male and female participants before and after bariatric surgery.
Change in Insulin Sensitivity	0.000552758 dL/kg/min/μU/mL Standard Deviation 0.000634641

SECONDARY outcome

Timeframe: Prior to bariatric surgery and 1 year post-bariatric surgery

Mixed meal tolerance test (MMTT): Peak glucose concentration (mg/dL) during 4 hour MMTT with 16 time points.

Outcome measures

Measure	Teenagers 13-20 Years Old in Bariatric Surgery Program n=6 Participants 13-20 year old male and female participants before and after bariatric surgery.
Change in Peak Glucose	11.5 mg/dL Standard Deviation 14.802

SECONDARY outcome

Timeframe: Prior to bariatric surgery and 1 year post-bariatric surgery

Mixed meal tolerance test (MMTT): Minimum glucose concentration (mg/dL) during 4 hour MMTT with 16 time points.

Outcome measures

Measure	Teenagers 13-20 Years Old in Bariatric Surgery Program n=6 Participants 13-20 year old male and female participants before and after bariatric surgery.
Change in Minimum Glucose	-7 mg/dL Standard Deviation 15.192

SECONDARY outcome

Timeframe: Prior to bariatric surgery and 1 year post-bariatric surgery

Mixed meal tolerance test (MMTT): Peak insulin concentration (uIU/mL) during 4 hour MMTT with 13 time points.

Outcome measures

Measure	Teenagers 13-20 Years Old in Bariatric Surgery Program n=6 Participants 13-20 year old male and female participants before and after bariatric surgery.
Change in Peak Insulin	28.333 uIU/mL Standard Deviation 62.746

SECONDARY outcome

Timeframe: Prior to bariatric surgery and 1 year post-bariatric surgery

Mixed meal tolerance test (MMTT): Minimum insulin concentration (uIU/mL) during 4 hour MMTT with 13 time points.

Outcome measures

Measure	Teenagers 13-20 Years Old in Bariatric Surgery Program n=6 Participants 13-20 year old male and female participants before and after bariatric surgery.
Change in Minimum Insulin	-7.333 uIU/mL Standard Deviation 3.7771

SECONDARY outcome

Timeframe: Prior to bariatric surgery and 1 year post-bariatric surgery

Mixed meal tolerance test (MMTT): Peak c-peptide concentration (ng/mL) during 4 hour MMTT with 10 time points.

Outcome measures

Measure	Teenagers 13-20 Years Old in Bariatric Surgery Program n=6 Participants 13-20 year old male and female participants before and after bariatric surgery.
Change in Peak C-peptide	1.7 ng/mL Standard Deviation 3.2323

SECONDARY outcome

Timeframe: Prior to bariatric surgery and 1 year post-bariatric surgery

Mixed meal tolerance test (MMTT): Peak GLP-1 concentration (pmol/L) during 4 hour MMTT with 9 time points.

Outcome measures

Measure	Teenagers 13-20 Years Old in Bariatric Surgery Program n=6 Participants 13-20 year old male and female participants before and after bariatric surgery.
Change in Peak GLP-1	-7.1117 pmol/L Standard Deviation 36.883

SECONDARY outcome

Timeframe: Prior to bariatric surgery and 1 year post-bariatric surgery

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.

Outcome measures

Measure	Teenagers 13-20 Years Old in Bariatric Surgery Program n=6 Participants 13-20 year old male and female participants before and after bariatric surgery.
Change in Fasting Glucagon	-41.333 pg/mL Standard Deviation 32.672

SECONDARY outcome

Timeframe: Prior to bariatric surgery and 1 year post-bariatric surgery

Population: Participants that completed pre-op and post-op study visits including valid MRE at each visit.

Change from baseline in degree of hepatic stiffness, measured with Magnetic Resonance elastography (MRE).

Outcome measures

Measure	Teenagers 13-20 Years Old in Bariatric Surgery Program n=4 Participants 13-20 year old male and female participants before and after bariatric surgery.
Change in Liver Stiffness Per MRI	-0.234 kPa Standard Deviation 0.508

SECONDARY outcome

Timeframe: At the time of surgery

Population: 14 participants completed in-surgery study measures, regardless of participation in pre-op or post-op MMTTs.

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.

Outcome measures

Measure	Teenagers 13-20 Years Old in Bariatric Surgery Program n=14 Participants 13-20 year old male and female participants before and after bariatric surgery.
Mitochondrial Function in the Liver Assessed by Oroboros Carbohydrate L/E Coupling Control Ratio	0.34 Coupling Control Ratio (unitless) Standard Deviation 0.06
Mitochondrial Function in the Liver Assessed by Oroboros Lipid L/E Coupling Control Ratio	0.50 Coupling Control Ratio (unitless) Standard Deviation 0.9

SECONDARY outcome

Timeframe: At the time of surgery

Population: Number of patients that had a liver 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.

Outcome measures

Measure	Teenagers 13-20 Years Old in Bariatric Surgery Program n=15 Participants 13-20 year old male and female participants before and after bariatric surgery.
Hepatic Steatosis Score Via Tissue Biopsy NAFLD Activity Score: 0 NAS ≤ 3 correlated with a diagnosis of "not NASH"	3 participants
Hepatic Steatosis Score Via Tissue Biopsy NAFLD Activity Score: 1 NAS ≤ 3 correlated with a diagnosis of "not NASH"	1 participants
Hepatic Steatosis Score Via Tissue Biopsy NAFLD Activity Score: 2 NAS ≤ 3 correlated with a diagnosis of "not NASH"	3 participants
Hepatic Steatosis Score Via Tissue Biopsy NAFLD Activity Score: 3 NAS ≤ 3 correlated with a diagnosis of "not NASH"	4 participants
Hepatic Steatosis Score Via Tissue Biopsy NAFLD Activity Score: 4	3 participants
Hepatic Steatosis Score Via Tissue Biopsy NAFLD Activity Score: 5 NAS score of ≥ 5 strongly correlated with a diagnosis of "definite NASH"	1 participants

Adverse Events

Teenagers 13-20 Years Old in Bariatric Surgery Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yesenia Garcia Reyes

University of Colorado

Phone: 720-777-6984

Email: Yesenia.GarciaReyes@childrenscolorado.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place