- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04357964
Beige Fat, Energy, and the Natriuretic Peptide System
August 23, 2023 updated by: VA Office of Research and Development
Beige Fat, Energy, and the Natriuretic Peptide System (ENDA-025-17S)
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 diseases.
NP levels differ by obesity status and race has not been established in humans.
Thus, the investigators propose a study in which will quantify adipose tissue gene expression and energy expenditure in states of NP deficiency in humans.
The overarching postulate is that obese and black individuals have NP deficiencies that contribute to less beige adipose tissue and lower energy expenditure.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
Obesity represents a serious public health burden.
Obese individuals experience increased risk of cardiovascular and metabolic cardiometabolic disease, including insulin diabetes, resistance, hypertension, and dyslipidemia.
Obesity and obesity-associated cardiometabolic dysfunction are significant contributors to morbidity and mortality in Veterans.
This indicates that obesity and cardiometabolic dysfunction are complex and multifactorial, and suggests that there are additional factors that contribute to the pathogenesis of obesity and its associated cardiometabolic risk that have been discovered.
Moreover, some of the pharmacologic therapies for obesity can have adverse cardiovascular effects.
Thus, it is crucial to improve the understanding of the multiple pathways contributing to the pathogenesis of obesity and obesity-associated cardiometabolic risk, including the identification of novel relevant pathways, in order to develop more effective treatments for these diseases.
The proposed work will form a foundation for future high-impact studies of mechanisms for adiposity and cardiometabolic disease.
Study Type
Observational
Enrollment (Actual)
77
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rachel L Turgeon, MS
- Phone Number: (615) 421-8235
- Email: rachel.l.turgeon@vumc.org
Study Contact Backup
- Name: Katherine N Bachmann, MD
- Phone Number: (615) 875-9520
- Email: Katherine.n.bachmann@vanderbilt.edu
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
-
Nashville, Tennessee, United States, 37212-2637
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Healthy volunteers who are U.S. veterans
Description
Inclusion Criteria:
- 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 Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
obese and lean individuals
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adipose tissue gene expression of UCP1 (Uncoupling Protein 1)- differences by obesity status
Time Frame: Study Day 1
|
Primary endpoint is adipose tissue gene expression of UCP1 (Uncoupling Protein 1)- differences by obesity status.
|
Study Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Associations of adipose tissue gene expression of UCP1 with natriuretic peptide markers
Time Frame: Study Day 1
|
The investigators will determine associations of adipose tissue gene expression of UCP1 with natriuretic peptide markers (natriuretic peptide receptor gene expression in adipose tissue, and circulating natriuretic peptide levels)
|
Study Day 1
|
adipose tissue gene expression of UCP1 (Uncoupling Protein 1)- differences by race
Time Frame: Study Day 1
|
The investigators will determine adipose tissue gene expression of UCP1 (Uncoupling Protein 1), and analyze differences by race (blacks compared with whites).
|
Study Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Katherine Neubecker Bachmann, MD, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 13, 2020
Primary Completion (Actual)
October 31, 2022
Study Completion (Estimated)
October 31, 2023
Study Registration Dates
First Submitted
April 14, 2020
First Submitted That Met QC Criteria
April 21, 2020
First Posted (Actual)
April 22, 2020
Study Record Updates
Last Update Posted (Actual)
August 24, 2023
Last Update Submitted That Met QC Criteria
August 23, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ENDA-025-17S-1
- 1IK2CX001678 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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