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| ID | Type | Description | Link |
|---|---|---|---|
| 24TPA1301309 | Other Grant/Funding Number | American Heart Association |
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Changes in adipose tissue biology are now recognized as a key factor underlying the increased risk of metabolic and cardiovascular disease with obesity. Clinical interest in adipocyte-derived extracellular vesicles (Ad-EVs) has intensified due to their potential as circulating biomarkers of adipose tissue health and systemic messengers, regulators and mediators of cardiometabolic health and disease with obesity.
The investigators hypothesize that elevated Ad-EVs in adults with obesity will be negatively associated with endothelium-dependent vasodilation. Furthermore, the investigators hypothesize that in adults with obesity, intentional weight loss-induced reduction in circulating Ad-EVs is associated with greater endothelium-dependent vasodilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Intervention: Phase 1 | No Intervention | Phase 1 is a cross-sectional study to compare whether circulating Ad-EVs are associated with obesity-related endothelial dysfunction in normal weight adults and adults with obesity. | |
| Experimental: Phase 2 | Experimental | Phase 2 employs an intervention study design, to determine in adults with obesity, the effects of intentional weight loss (12-weeks) on circulating Ad-EVs and their effect on endothelium-dependent vasodilation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight loss without pharmacotherapy | Other | Adults with obesity participating in the 12-week hypocaloric diet-induced weight loss intervention will be individually counseled by the Clinical and Translational Research Center (CTRC) bionutritionist to consume a hypocaloric diet consistent with current dietary recommendations for weight loss until a 6-10% weight loss is achieved. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Circulating adipocyte-derived extracellular vesicles (Ad-EVs) | Circulating Ad-EVs will be determined from a peripheral blood sample in normal weight and obese adults. Ad-EVs will be determined using flow cytometry. The samples will be incubated with perilipin A. Ad-EVs will be defined as perilipin A positive cells ranging in size 0.2-0.8 um. | Circulating Ad-EVs will measured during Phase 1 visit 2 which is ~2 weeks from their respective start date. |
| Phase 2: Circulating adipocyte-derived extracellular vesicles (Ad-EVs) | Circulating Ad-EVs will be determined from a peripheral blood sample following the obese participants 12-week weight loss intervention. | Circulating Ad-EVs will be measured during Phase 2 visit 15 which is ~17 weeks from their respective start date. |
| Phase 1: Forearm Blood Flow (FBF) Response to Acetylcholine (ACh) | FBF is measured via strain-gauge venous occlusion plethysmography in response to saline for 5 minutes and then to ACh (4.0, 8.0 and 16.0 ug/100 mL tissue/min; the doses of ACh infused into the brachial artery) for 5 minutes at each dose. Flows during the last minute of saline and each drug dose are measured and the mean value reported. | FBF response to ACh will be measured during Phase 1 and the participant's visit 2 which is ~ 2 weeks from their respective start date. |
| Phase 2: Forearm Blood Flow (FBF) Response to Acetylcholine (ACh) | FBF is measured via strain-gauge venous occlusion plethysmography in response to saline for 5 minutes and then to ACh (4.0, 8.0 and 16.0 ug/100 mL tissue/min; the doses of ACh infused into the brachial artery) for 5 minutes at each dose. Flows during the last minute of saline and each drug dose are measured and the mean value reported. | FBF response to ACh will be measured during Phase 2 and the participant's visit 15 which is ~17 weeks from their respective start date. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jared Greiner, MS | Contact | 303-735-3605 | greinerj@colorado.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christopher DeSouza, PhD | University of Colorado, Boulder | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Boulder Clinical and Translational Research Center (CTRC) | Recruiting | Boulder | Colorado | 80309 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Phase 1: Forearm Blood Flow (FBF) Response to Sodium Nitroprusside (NTP) |
FBF is measured via strain-gauge venous occlusion plethysmography in response to saline for 5 minutes and then to NTP (1.0, 2.0 and 4.0 ug/100 mL tissue/min; the doses of NTP infused into the brachial artery) for 5 minutes at each dose. Flows during the last minute of saline and each drug dose are measured and the mean value reported. |
| FBF response to NTP will be measured during Phase 1 and the participant's visit 2 which is ~ 2 weeks from their respective start date. |
| Phase 2: Forearm Blood Flow (FBF) Response to Sodium Nitroprusside (NTP) | FBF is measured via strain-gauge venous occlusion plethysmography in response to saline for 5 minutes and then to NTP (1.0, 2.0 and 4.0 ug/100 mL tissue/min; the doses of NTP infused into the brachial artery) for 5 minutes at each dose. Flows during the last minute of saline and each drug dose are measured and the mean value reported. | FBF response to NTP will be measured during Phase 2 and the participant's visit 15 which is ~17 weeks from their respective start date. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |