Other

Weight Loss for Obesity

Boulder, CO

N/A

Recruiting

Led By Christopher DeSouza, PhD

Research Sponsored by University of Colorado, Boulder

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥40 years

BMI <25 kg/m2 for Phase 1

Must not have

Stage III hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg)

Women who are pregnant or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up circulating ad-evs will be measured during phase 2 visit 15 which is ~17 weeks from their respective start date.

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at how changes in fat tissue can affect the risk of metabolic and heart diseases in obese individuals. They are studying a type of particles released by fat cells called Ad-EVs, which

Who is the study for?

This trial is for adults with obesity who are interested in losing weight without using drugs. The study focuses on how fat cells communicate and influence heart health during weight loss.

What is being tested?

The study looks at the effects of intentional weight loss on tiny particles released by fat cells, called Ad-EVs, and their relationship to blood vessel function.

What are the potential side effects?

Since this trial involves non-drug methods of weight loss, side effects may include typical responses to diet or lifestyle changes such as fatigue, hunger, or mood swings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 40 years old or older.

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My BMI is under 25.

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My BMI is over 25.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My blood pressure is very high (>160/100 mmHg).

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I am not pregnant or breastfeeding.

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I am currently taking statin medication.

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I have Raynaud's disease.

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I have a history of blood clotting disorders.

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I am currently taking medication for blood thinning or clotting.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ circulating ad-evs will be measured during phase 2 visit 15 which is ~17 weeks from their respective start date.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~circulating ad-evs will be measured during phase 2 visit 15 which is ~17 weeks from their respective start date.

This trial's timeline: 3 weeks for screening, Varies for treatment, and circulating ad-evs will be measured during phase 2 visit 15 which is ~17 weeks from their respective start date. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1: Circulating adipocyte-derived extracellular vesicles (Ad-EVs)

Phase 1: Forearm Blood Flow (FBF) Response to Acetylcholine (ACh)

Phase 1: Forearm Blood Flow (FBF) Response to Sodium Nitroprusside (NTP)

+3 more

Side effects data

From 2020 Phase 2 trial • 100 Patients • NCT02496611

73%

Injection Site Reaction

42%

Headache

39%

Upper respiratory infection

21%

Nausea

18%

Diarrhea

18%

Constipation

12%

Dyspepsia

12%

Flu-like symptoms

Abdominal pain

Dizziness

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Weight Loss Maintenance Without Pharmacotherapy

Weight Loss Maintenance With Pharmacotherapy

Meal Replacement Induction

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental: Phase 2Experimental Treatment1 Intervention

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.

Group II: No Intervention: Phase 1Active Control1 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.

0 / 9Eligibility criteria met