Study Results
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View full resultsBasic Information
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COMPLETED
137 participants
OBSERVATIONAL
2020-04-13
2022-10-31
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
Study Groups
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obese and lean individuals
obese and lean individuals
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) \>= 18.5 and \<25 kg/m2 (lean), or BMI 30 kg/m2 (obese)
Exclusion Criteria
* Heart failure (any type) or unstable coronary artery disease
* Diabetes Mellitus (Types 1 and 2)
* Thyroid dysfunction
* Active malignancy
* Chronic inflammatory diseases, such as inflammatory bowel disease, hepatitis, rheumatoid arthritis
* Current use of medications likely to affect energy homeostasis, including glucocorticoids, amphetamines, and beta blockers
* Currently pregnant or breastfeeding, or unwilling to avoid becoming pregnant or breastfeeding during study duration
* Significant claustrophobia that would prevent the use of the metabolic cart as part of the study protocol
* Hemoglobin A1c (HbA1c) \>= 6.5%
* Liver Function Tests (LFTs) elevated \>3x upper limit of normal
* Estimated Glomerular Filtration Rate (eGFR) \<40 ml/min
* Currently abnormal thyroid stimulating hormone (TSH)
18 Years
55 Years
ALL
Yes
Sponsors
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Vanderbilt University Medical Center
OTHER
VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Alp Ikizler, MD
Role: PRINCIPAL_INVESTIGATOR
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Locations
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VA TVHS Nashville
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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ENDA-025-17S-1
Identifier Type: -
Identifier Source: org_study_id
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