Study Results
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View full resultsBasic Information
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COMPLETED
20 participants
OBSERVATIONAL
2018-11-20
2023-06-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. BMI 35-55 m2/kg
3. Maximal body circumference \<200 cm
Exclusion Criteria
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
13 Years
20 Years
ALL
No
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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18-0479
Identifier Type: -
Identifier Source: org_study_id
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