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Assess the impact of bariatric surgery on hepatic energy metabolism and glucose and insulin dynamics in obese youth
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals age 13-20 years; Body Mass Index 35-55 m2/kg; Scheduled for Bariatric Surgery at Children's Hospital Colorado.
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| Name | Affiliation | Role |
|---|---|---|
| Melanie Cree-Green, MD, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anshutz Medical Campus/Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Teenagers 13-20 Years Old in Bariatric Surgery Program | 13-20 year old male and female participants before and after bariatric surgery. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Teenagers 13-20 Years Old in Bariatric Surgery Program | 13-20 year old male and female participants before and after bariatric surgery. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percentage of liver fat | Prior to bariatric surgery and 1 year post-bariatric surgery |
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Duration of study participation, about 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Teenagers 13-20 Years Old in Bariatric Surgery Program | 13-20 year old male and female participants before and after bariatric surgery. |
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Limited by small sample size due to participant withdraw.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yesenia Garcia Reyes | University of Colorado | 720-777-6984 | Yesenia.GarciaReyes@childrenscolorado.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 14, 2022 | Apr 11, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D063766 | Pediatric Obesity |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
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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.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | At the time of surgery |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Primary | 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. | Posted | Mean | Standard Deviation | change in percentage of Direct TG-Glycer | Prior to bariatric surgery and 1 year post-bariatric surgery |
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| Secondary | 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. | Posted | Mean | Standard Deviation | dL/kg/min/μU/mL | Prior to bariatric surgery and 1 year post-bariatric surgery |
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| Secondary | Change in Peak Glucose | Mixed meal tolerance test (MMTT): Peak glucose concentration (mg/dL) during 4 hour MMTT with 16 time points. | Posted | Mean | Standard Deviation | mg/dL | Prior to bariatric surgery and 1 year post-bariatric surgery |
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| Secondary | Change in Minimum Glucose | Mixed meal tolerance test (MMTT): Minimum glucose concentration (mg/dL) during 4 hour MMTT with 16 time points. | Posted | Mean | Standard Deviation | mg/dL | Prior to bariatric surgery and 1 year post-bariatric surgery |
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| Secondary | Change in Peak Insulin | Mixed meal tolerance test (MMTT): Peak insulin concentration (uIU/mL) during 4 hour MMTT with 13 time points. | Posted | Mean | Standard Deviation | uIU/mL | Prior to bariatric surgery and 1 year post-bariatric surgery |
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| Secondary | Change in Minimum Insulin | Mixed meal tolerance test (MMTT): Minimum insulin concentration (uIU/mL) during 4 hour MMTT with 13 time points. | Posted | Mean | Standard Deviation | uIU/mL | Prior to bariatric surgery and 1 year post-bariatric surgery |
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| Secondary | Change in Peak C-peptide | Mixed meal tolerance test (MMTT): Peak c-peptide concentration (ng/mL) during 4 hour MMTT with 10 time points. | Posted | Mean | Standard Deviation | ng/mL | Prior to bariatric surgery and 1 year post-bariatric surgery |
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| Secondary | Change in Peak GLP-1 | Mixed meal tolerance test (MMTT): Peak GLP-1 concentration (pmol/L) during 4 hour MMTT with 9 time points. | Posted | Mean | Standard Deviation | pmol/L | Prior to bariatric surgery and 1 year post-bariatric surgery |
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| Secondary | 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. | Posted | Mean | Standard Deviation | pg/mL | Prior to bariatric surgery and 1 year post-bariatric surgery |
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| Secondary | Change in Liver Stiffness Per MRI | Change from baseline in degree of hepatic stiffness, measured with Magnetic Resonance elastography (MRE). | Participants that completed pre-op and post-op study visits including valid MRE at each visit. | Posted | Mean | Standard Deviation | kPa | Prior to bariatric surgery and 1 year post-bariatric surgery |
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| Secondary | 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. | 14 participants completed in-surgery study measures, regardless of participation in pre-op or post-op MMTTs. | Posted | Mean | Standard Deviation | Coupling Control Ratio (unitless) | At the time of surgery |
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| Secondary | 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. | Number of patients that had a liver tissue biopsy. | Posted | Number | participants | At the time of surgery |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| NAFLD Activity Score: 3 NAS ≤ 3 correlated with a diagnosis of "not NASH" |
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| NAFLD Activity Score: 4 |
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| NAFLD Activity Score: 5 NAS score of ≥ 5 strongly correlated with a diagnosis of "definite NASH" |
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