An observational study in Obesity, sponsored by VA Office of Research and Development. Completed at 2 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-01.
Sponsored by VA Office of Research and Development · Observational
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.
This study's enrollment of 137 is close to the median of 135 across 1,283 observational studies indexed under Obesity.
Browse Obesity studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Healthy volunteers who are U.S. veterans
Exclusion Criteria:
obese and lean individuals
Adipose Tissue Gene Expression of UCP1 (Uncoupling Protein 1)- Differences by Obesity Status
Primary endpoint is adipose tissue gene expression of UCP1 (Uncoupling Protein 1)- differences by obesity status (obese vs. lean). Units for primary endpoint are relative UCP1 gene expression (quantified using quantitative real-time reverse-transcription polymerase chain reaction (qRT-PCR)), normalized to a housekeeping gene.
Time frame: Study Day 1
Associations of Adipose Tissue Gene Expression of UCP1 (Uncoupling Protein 1) With Natriuretic Peptide Markers
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)
Time frame: Study Day 1
Adipose Tissue Gene Expression of UCP1 (Uncoupling Protein 1)- Differences by Race
The investigators will determine adipose tissue gene expression of UCP1 (Uncoupling Protein 1), and analyze differences by race (blacks compared with whites).
Time frame: Study Day 1
| Milestone | Lean Individuals | Obese Individuals |
|---|---|---|
| Started | 55 | 82 |
| Completed | 37 | 81 |
| Not completed | 18 | 1 |
| Withdrew: Deemed not to have enough sufficient adipose tissue to undergo subcutaneous adipose biopsy | 5 | 0 |
| Withdrew: Did not have usable primary endpoint data due to insufficient or low-quality adipose sample | 13 | 0 |
| Withdrew: Adipose sample was insufficient quality | 0 | 1 |
Primary endpoint is adipose tissue gene expression of UCP1 (Uncoupling Protein 1)- differences by obesity status (obese vs. lean). Units for primary endpoint are relative UCP1 gene expression (quantified using quantitative real-time reverse-transcription polymerase chain reaction (qRT-PCR)), normalized to a housekeeping gene.
| fold change | Lean Individuals | Obese Individuals |
|---|---|---|
| Adipose Tissue Gene Expression of UCP1 (Uncoupling Protein 1)- Differences by Obesity Status | 7.79 (3.26 to 16.33) | 24.33 (16.5 to 40.93) |
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)
| correlation coefficient | Obese and Lean Individuals |
|---|---|
| Associations of Adipose Tissue Gene Expression of UCP1 (Uncoupling Protein 1) With Natriuretic Peptide Markers | 0.28 |
The investigators will determine adipose tissue gene expression of UCP1 (Uncoupling Protein 1), and analyze differences by race (blacks compared with whites).
| fold change | Race: Blacks | Race: Whites |
|---|---|---|
| Adipose Tissue Gene Expression of UCP1 (Uncoupling Protein 1)- Differences by Race | 14.7 (11.2 to 28.5) | 20.9 (10.0 to 37.3) |
Collected over Approximately 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lean Individuals | 8/55 (14.5%) | 0/55 (0%) | 8/55 (14.5%) |
| Obese Individuals | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Event | Lean Individuals | Obese Individuals |
|---|---|---|
| Local skin reactionSkin and subcutaneous tissue disorders | 4/55 | 0/22 |
| LightheadedVascular disorders | 3/55 | 0/22 |
| NauseaGastrointestinal disorders | 2/55 | 0/22 |
| Age, Continuous(years) | Lean Individuals | Obese Individuals | Total |
|---|---|---|---|
| Median | 39 (31.5 to 48) | 52 (41.0 to 57.0) | 47 (37.5 to 54) |
| Sex: Female, Male(Participants) | Lean Individuals | Obese Individuals | Total |
|---|---|---|---|
| Female | 11 | 50 | 61 |
| Male | 26 | 31 | 57 |
| Race (NIH/OMB)(Participants) | Lean Individuals | Obese Individuals | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 14 | 19 |
| White | 31 | 64 | 95 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 3 | 4 |
| Region of Enrollment(Participants) | Lean Individuals | Obese Individuals | Total |
|---|---|---|---|
| United States | 37 | 81 | 118 |
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VA Office of Research and Development