ObesityNCT06776081
Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function
A study testing Weight loss without pharmacotherapy in people with Obesity and Weight Loss, run by University of Colorado, Boulder at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Weight loss without pharmacotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Boulder Clinical and Translational Research Center (CTRC)
Boulder, Colorado, 80309
Jared Greiner, MS, 303-735-3056, greinerj@colorado.edu
About this study
Official title: Adipocyte-Derived Extracellular Vesicles; Novel Biomarker and Mediator of Obesity-Related Endothelial Dysfunction
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.
- Conditions
- Obesity, Weight Loss
- Being tested
- Weight loss without pharmacotherapy
- Keywords
- Obesity, Weight Loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss without pharmacotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Weight loss without pharmacotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Jul 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher DeSouza, University of Colorado, Boulder
- Investigators
- Christopher DeSouza, PhD, Principal investigator, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776081
- Sponsor's protocol ID
- 24-0523
- Other IDs
- 24TPA1301309
- Status last verified
- Apr 2026
- First submitted
- 9 Jan 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipocyte-Derived Extracellular Vesicles; Novel Biomarker and Mediator of Obesity-Related Endothelial Dysfunction
- ClinicalTrials.gov ID
- NCT06776081
- Acronym / sponsor ID
- 24-0523
- Conditions
- Obesity, Weight Loss
- Keywords
- Obesity, Weight Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Weight loss without pharmacotherapyPhase 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight loss without pharmacotherapyAdults 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. | Other | Experimental: Phase 2 |
Primary outcome
Phase 1: Circulating adipocyte-derived extracellular vesicles (Ad-EVs)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher DeSouza, PhD principal investigator
University of Colorado, Boulder
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss without pharmacotherapy in people with Obesity and Weight Loss, run by University of Colorado, Boulder at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jared Greiner, MS (303-735-3605, greinerj@colorado.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Circulating adipocyte-derived extracellular vesicles (Ad-EVs) (time frame: Circulating Ad-EVs will measured during Phase 1 visit 2 which is ~2 weeks from their respective start date.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.