Status:
COMPLETED
Beige Fat, Energy, and the Natriuretic Peptide System
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Vanderbilt University Medical Center
Conditions:
Obesity
Eligibility:
All Genders
18-55 years
Brief Summary
Obese individuals experience an increased risk of cardiovascular and metabolic diseases. Evidence from genetic studies indicate that the natriuretic peptide (NP) system may protect against these disea...
Detailed Description
Obesity represents a serious public health burden. Obese individuals experience increased risk of cardiovascular and metabolic cardiometabolic disease, including insulin diabetes, resistance, hyperten...
Eligibility Criteria
Inclusion
- Men and women ages 18-55 years
- Body Mass Index (BMI) \>= 18.5 and \<25 kg/m2 (lean), or BMI 30 kg/m2 (obese)
Exclusion
- Significant pulmonary, liver, or renal disease
- 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)
Key Trial Info
Start Date :
April 13 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT04357964
Start Date
April 13 2020
End Date
October 31 2022
Last Update
August 1 2024
Active Locations (2)
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1
VA TVHS Nashville
Nashville, Tennessee, United States, 37212
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212