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Weight Loss and Blood Vessel Health Study

This study is looking at how weight loss, achieved through a 12-week special diet, affects certain tiny particles in your blood called adipocyte-derived extracellular vesicles (Ad-EVs) and the health of your blood vessels. Researchers believe that high levels of Ad-EVs in people with obesity might be linked to less healthy blood vessels. They also think that losing weight could lower these Ad-EVs and improve blood vessel health. The study aims to enroll 84 adults, aged 40 and older, who have obesity (BMI over 25 kg/m2). You cannot join if you smoke or have certain chronic health conditions like heart disease or diabetes. The study will measure Ad-EVs and blood vessel function at different times over about 17 weeks.

Study design
This is an interventional study planning to enroll 84 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will follow a 12-week hypocaloric diet with counseling. Measurements of Ad-EVs and forearm blood flow will be taken at approximately 2 weeks and 17 weeks from the start date.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for approximately 17 weeks from their start date.

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NCT06776081

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

Recruiting
NAAges 40+InterventionalBasic science
University of Colorado, Boulder
~84 participants
Updated 2026-04-28 on ClinicalTrials.gov
What's tested:Weight loss without pharmacotherapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1: Circulating adipocyte-derived extracellular vesicles (Ad-EVs)
Measured over Circulating Ad-EVs will measured during Phase 1 visit 2 which is ~2 weeks from their respective start date.
+5 more outcomes measured

Conditions

Obesity
Weight Loss

Explore related trials

Obesity

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Christopher DeSouza, PhD · PRINCIPAL_INVESTIGATOR · University of Colorado, Boulder

Who to contact

Jared Greiner, MS
[email protected]
303-735-3605
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥40 years
BMI \<25 kg/m2 and BMI \>25 kg/m2 for Phase 1 and BMI \>25 kg/m2 for Phase 2. Rationale for defining obesity as BMI \>25 kg/m2

Exclusion

Current smoker
Chronic overt medical condition (e.g., evidence of coronary artery disease on resting ECG, any history of myocardial infarction or stroke, or cancer, diabetes based on fasting blood glucose concentration)
Alcohol abuse or dependence defined as more than 14 standard drinks/week and no more than 4 standard drinks/day for men and 7 standard drinks/week and 3 standard drinks/day for women (a standard drink is defined as 12 ounces of beer, 5 ounces of wines, 1 ½ ounces of 80-proof distilled spirits) reported during the medical history/physical exam
Stage III hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg)
Regular vigorous aerobic/endurance exercise (\>3 bouts/week, \>30 minutes/bout at a workload \>6 METS)
Women who are pregnant or breastfeeding
History of anaphylaxis to betadine, lidocaine, iodine
Raynaud's disease
History of clotting disorders
Anyone taking blood thinners and clotting medications
Anyone taking statin medication
Planned pregnancy in coming 4-6 months

What this trial measures

  • 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.