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New treatment option for Obesity
Official title Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function
ClinicalTrials.gov ID: NCT06776081
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older. Healthy volunteers may be eligible.
You may be able to join if
- Age ≥40 years
- BMI \ 25 kg/m2 for Phase 1 and BMI \>25 kg/m2 for Phase 2. Rationale for defining obesity as BMI \>25 kg/m2
You likely can't join if
- 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...
- 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...
- 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
See the full eligibility criteria
- Age ≥40 years
- BMI \ 25 kg/m2 for Phase 1 and BMI \>25 kg/m2 for Phase 2. Rationale for defining obesity as BMI \>25 kg/m2
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boulder, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boulder, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.