Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1IK2CX001678 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Vanderbilt University Medical Center | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| obese and lean individuals | obese and lean individuals |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Study Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Study Day 1 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Healthy volunteers who are U.S. veterans
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alp Ikizler, MD | Tennessee Valley Healthcare System Nashville Campus, Nashville, TN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA TVHS Nashville | Nashville | Tennessee | 37212 | United States | ||
| Vanderbilt University Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Enrolled subjects underwent a screening visit to determine eligibility for the study. The screening visit included a medical history, physical examination, calculation of BMI, and a blood draw for CMP, CBC, HbA1c, TSH, and free T4. A pregnancy test was completed on female subjects of child-bearing potential. Eligible subjects who still wished to participate in the study were then enrolled for the main study visit.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lean Individuals | Body Mass Index (BMI) ≥18.5 and <25 kg/m2 (As defined per protocol) |
| FG001 | Obese Individuals | BMI ≥30 kg/m2 (as defined by protocol) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lean Individuals | lean individuals (BMI >= 18.5 and <25 kg/m2) |
| BG001 | Obese Individuals | obese individuals (BMI>= 30 kg/m2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants who had data for primary endpoint (adipose tissue UCP1 gene expression). | Posted | Median | Inter-Quartile Range | fold change | Study Day 1 |
|
Approximately 1 year
A total of 22 obese individuals underwent procedures in the current study and thus there were 22 obese individuals "at risk" for an AE in the present study. Separately, we analyzed the baseline samples/data from 60 obese individuals from a previously conducted study, but these subjects were not "at risk" for an adverse event in the present study since they did not undergo procedures in the present study. AE's from this previous study are listed at: https://clinicaltrials.gov/study/NCT03101930.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lean Individuals | BMI ≥18.5 and <25 kg/m2 (as defined by protocol) | 8 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Local skin reaction | Skin and subcutaneous tissue disorders | Systematic Assessment | Redness, bruising or tenderness around biopsy site. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alp Ikizler, Catherine McLaughlin Hakim Chair in Vascular Biology, Professor of Medicine | Vanderbilt University Medical Center | (615) 343-7592 | alp.ikizler@vumc.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2023 | Oct 27, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 29, 2022 | May 8, 2023 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood, urine, and fat biopsy samples
| 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). | Study Day 1 |
| Nashville |
| Tennessee |
| 37212 |
| United States |
| Adipose sample was insufficient quality |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
obese individuals (BMI>= 30 kg/m2)
|
|
|
| Secondary | 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) | Correlation between UCP1 gene expression and natriuretic peptide receptor-C (NPR-C) gene expression. The groups are combined in this analysis because the investigators had pre-specified that this secondary outcome would analyze this correlation across all individuals (lean and obese combined) for whom gene expression data was available. | Posted | Number | correlation coefficient | Study Day 1 |
|
|
|
|
| Secondary | 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). | All participants who had data for primary endpoint (adipose tissue UCP1 gene expression), and who also self-reported their race as "white" or "black". | Posted | Median | Inter-Quartile Range | fold change | Study Day 1 |
|
|
|
|
| 55 |
| 0 |
| 55 |
| 8 |
| 55 |
| EG001 | Obese Individuals | BMI ≥30 kg/m2 (as defined by protocol) A total of 22 obese individuals underwent procedures in the current study and thus there were 22 obese individuals "at risk" for an adverse event in the present study. Separately, we analyzed the samples/data from 60 obese individuals from a previously conducted study, but these subjects were not "at risk" for an adverse event in the present study since they did not undergo procedures in the present study. | 0 | 22 | 0 | 22 | 0 | 22 |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Experience nausea during the biopsy procedure. |
|
| Lightheaded | Vascular disorders | Systematic Assessment | Experienced lightheadedness during biopsy procedure. |
|
Not provided
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |