Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function

Not Applicable

Recruiting

• Conditions: Obesity; Weight Loss

• Registration Number: NCT06776081
• Lead Sponsor: University of Colorado, Boulder

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Phase 1: Circulating adipocyte-derived extracellular vesicles (Ad-EVs)	Circulating Ad-EVs will measured during Phase 1 visit 2 which is ~2 weeks from their respective start date.	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.
Phase 2: Circulating adipocyte-derived extracellular vesicles (Ad-EVs)	Circulating Ad-EVs will be measured during Phase 2 visit 15 which is ~17 weeks from their respective start date.	Circulating Ad-EVs will be determined from a peripheral blood sample following the obese participants 12-week weight loss intervention.
Phase 1: Forearm Blood Flow (FBF) Response to Acetylcholine (ACh)	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.	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.
Phase 2: Forearm Blood Flow (FBF) Response to Acetylcholine (ACh)	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.	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.
Phase 1: Forearm Blood Flow (FBF) Response to Sodium Nitroprusside (NTP)	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.	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.
Phase 2: Forearm Blood Flow (FBF) Response to Sodium Nitroprusside (NTP)	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.	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.

Trial Locations

Locations (1)

University of Colorado Boulder Clinical and Translational Research Center (CTRC); 🇺🇸 Boulder, Colorado, United States