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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03587727
Other study ID # 18-0479
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 20, 2018
Est. completion date June 30, 2024

Study information

Verified date April 2024
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 19
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 13 Years to 20 Years
Eligibility 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-? or PPAR-a, 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

Study Design


Locations

Country Name City State
United States University of Colorado Anshutz Medical Campus/Children's Hospital Colorado Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent Change in Liver Fat per MRI Change from baseline in percent hepatic fat measured with MRI and calculated via the Dixon method as the proton density hepatic fat, which ranges from 0-75%. Prior to bariatric surgery and 1 year post-bariatric surgery
Primary Change in %Direct TG-Glycerol Appearance Change in %TG-Glycerol appearance from a labeled glycerol drink via direct pathway. Prior to bariatric surgery and 1 year post-bariatric surgery
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. Prior to bariatric surgery and 1 year post-bariatric surgery
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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. Prior to bariatric surgery and 1 year post-bariatric surgery
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. Prior to bariatric surgery and 1 year post-bariatric surgery
Secondary Change in Fasting Glucagon Mixed meal tolerance test (MMT): Fasting glucagon concentration (pg/mL) at the beginning of a 4 hour MMTT. At time of surgery
Secondary 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
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. At the time of surgery
Secondary Baseline Hepatic Steatosis Score via Tissue NAFLD Activity Score (NAS) determined via liver tissue biopsy. 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). In patients with NAFLD, NAS score of = 5 strongly correlated with a diagnosis of "definite NASH" whereas NAS = 3 correlated with a diagnosis of "not NASH". At the time of surgery
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