Hepatic Mitochondrial Function in Youth

NCT ID: NCT03587727

Last Updated: 2025-10-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-20

Study Completion Date

2023-06-21

Brief Summary

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

Detailed Description

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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.

Conditions

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Hepatic Steatosis Bariatric Surgery Candidate Adolescent Obesity Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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-γ or PPAR-α, 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
Minimum Eligible Age

13 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melanie Cree-Green, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Anshutz Medical Campus/Children's Hospital Colorado

Aurora, Colorado, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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18-0479

Identifier Type: -

Identifier Source: org_study_id

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