ObesityNCT05199454
Role of Adiposomes in Endothelial Dysfunction
A study testing Exercise training in people with Obesity and Diabetes, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The development of type II diabetes (T2D) is strongly associated with obesity and both are well-established risk factors for cardiovascular disease. Knowing that vascular dysfunction is an early event in the development of cardiovascular disease in obese diabetic (OB-T2D) patients, The investigators set their… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obesity, Diabetes, Cardiovascular Diseases
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2022to 31 Dec 2026
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI ≥ 35 kg/m2
- Between ages 18-50 years
- Not pregnant
- Diabetic (Current use of diabetes medication or fasting glucose ≥126 mg/dL)
- Medical clearance to participate in a moderate-intensity exercise program
Who cannot join
- Pregnant women
- Current smokers
- Currently abusing alcohol or drugs
- Chronic heart, liver, or kidney diseases, autoimmune diseases, or cancer
- Non-English speakers
- History of allergic reactions to lidocaine
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 Illinois at Chicago
Chicago, Illinois, 60612
Abeer M Mohamed, MD, PhD, 312-355-8099, amahmo4@uic.edu
About this study
Official title: Role of Adiposomes in Diabetes-Associated Endothelial Dysfunction and Restorative Effects of Exercise and Metabolic Surgery
The development of type II diabetes (T2D) is strongly associated with obesity and both are well-established risk factors for cardiovascular disease. Knowing that vascular dysfunction is an early event in the development of cardiovascular disease in obese diabetic (OB-T2D) patients, The investigators set their long-term goal to define molecular mechanisms of vascular dysfunction and corrective strategies that target these mechanisms such as physical activity and weight loss. The investigators recently discovered that human adipose tissues release extracellular vesicles (adiposomes) that are efficiently captured by endothelial cells. Adiposomes are known to carry bioactive cargos such as proteins and micro RNAs; however, their lipid content has not been studied nor has their ability to transfer their lipid cargo to endothelial cells. In the current application, the investigators propose to investigate the role of adiposomes in communicating the unhealthy milieu, mainly dysregulated lipids, to endothelial cells in OB-T2D subjects. On top of these lipid species that the investigators propose to be carried by adiposomes are glycosphingolipids (GSLs). These lipids originate from the glycosylation of ceramides, a chemical process that is upregulated in the presence of inflammation and high glucose levels. Preliminary findings showed that in endothelial cells, GSL-rich adiposomes disturb plasma membrane structure and subsequently induce endothelial dysfunction. Moreover, the investigators found that preconditioning endothelial cells with high shear stress (which is an exercise mimetic) protected endothelial cells from the detrimental effects induced by adiposomes. Therefore, the central hypothesis is that adipose tissues in OB-T2D patients release GSL-loaded adiposomes that induce vascular endothelial dysfunction. The researchers propose that exercise and weight loss interventions (bariatric surgery) will restore adipose tissue homeostasis, reduce GSL-loaded adiposomes, and subsequently alleviate vascular risk in OB-T2D patients. The investigators will test the hypotheses by pursuing the following aims: aim 1: Investigate the role of GSL-rich adiposomes in the pathogenesis of endothelial dysfunction in OB-T2D adults; aim 2: Test the effectiveness of exercise training in reducing adiposome-mediated effects on vascular function; and aim 3: Examine changes in adiposome/caveolae axis following metabolic surgery and their association with vascular function.
- Conditions
- Obesity, Diabetes, Cardiovascular Diseases
- Being tested
- Exercise training
- Medical subject headings
- Obesity, Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Aerobic exercise training using a treadmill or a bike for 12 weeks, 3 times per week, 60 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | Aerobic exercise training for 12 weeks, 3 times per week, 60 minutes per session. Receives: Other: Exercise training |
| Control (standards of care) | No intervention | This arm will receive brochures for healthy lifestyle recommendations. No intervention will be conducted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery flow-mediated dilation (percent vasodilation) in 60 obese diabetic subjects
Brachial flow-mediated dilation will be measured using ultrasound Alpha 7. For recording, a linear probe will be positioned five centimeters above the left arm's antecubital fossa, and a 1-minute baseline imaging will be recorded. Then, a blood pressure cuff will be put around the right mid-forearm and inflated to 200 to 220 mmHg for 5 minutes. Following cuff deflation (reactive hyperemia), a video grabber will be used to record a 300-second video sequence at three frames per second for offline measurement. The greatest brachial artery diameter at baseline will be deducted from the largest mean values obtained following cuff deflation to determine relative flow mediated dilation
Measured: 4 years
Secondary outcomes (1)
Glycosphingolipid content (ng/ml) in adiposomes from 60 obese diabetic subjects
Adiposomes isolated from adipose tissue samples will be examined for their glycosphingolipid content using mass spectrometry and the outcome will be in nanograms per milliliter (ng/ml)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start16 May 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Abeer M. Mohamed, University of Illinois Chicago
- Investigators
- Abeer M Mohamed, MD, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199454
- Sponsor's protocol ID
- 2021-1113
- Other IDs
- 1R01HL161386-01
- Status last verified
- May 2026
- First submitted
- 19 Dec 2021
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Adiposomes in Diabetes-Associated Endothelial Dysfunction and Restorative Effects of Exercise and Metabolic Surgery
- ClinicalTrials.gov ID
- NCT05199454
- Acronym / sponsor ID
- 2021-1113
- Conditions
- Obesity, Diabetes, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 16 May 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jan 2022 (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.
The development of type II diabetes (T2D) is strongly associated with obesity and both are well-established risk factors for cardiovascular disease. Knowing that vascular dysfunction is an early event in the development of cardiovascular disease in obese diabetic (OB-T2D) patients, The investigators set their long-term goal to define molecular mechanisms of vascular dysfunction and corrective strategies that target these mechanisms such as physical activity and weight loss. The investigators recently discovered that human adipose tissues release extracellular vesicles (adiposomes) that are efficiently captured by endothelial cells. Adiposomes are known to carry bioactive cargos such as proteins and micro RNAs; however, their lipid content has not been studied nor has their ability to transfer their lipid cargo to endothelial cells. In the current application, the investigators propose to investigate the role of adiposomes in communicating the unhealthy milieu, mainly dysregulated lipids, to endothelial cells in OB-T2D subjects. On top of these lipid species that the investigators propose to be carried by adiposomes are glycosphingolipids (GSLs). These lipids originate from the glycosylation of ceramides, a chemical process that is upregulated in the presence of inflammation and high glucose levels. Preliminary findings showed that in endothelial cells, GSL-rich adiposomes disturb plasma membrane structure and subsequently induce endothelial dysfunction. Moreover, the investigators found that preconditioning endothelial cells with high shear stress (which is an exercise mimetic) protected endothelial cells from the detrimental effects induced by adiposomes. Therefore, the central hypothesis is that adipose tissues in OB-T2D patients release GSL-loaded adiposomes that induce vascular endothelial dysfunction. The researchers propose that exercise and weight loss interventions (bariatric surgery) will restore adipose tissue homeostasis, reduce GSL-loaded adiposomes, and subsequently alleviate vascular risk in OB-T2D patients. The investigators will test the hypotheses by pursuing the following aims: aim 1: Investigate the role of GSL-rich adiposomes in the pathogenesis of endothelial dysfunction in OB-T2D adults; aim 2: Test the effectiveness of exercise training in reducing adiposome-mediated effects on vascular function; and aim 3: Examine changes in adiposome/caveolae axis following metabolic surgery and their association with vascular function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Other: Exercise trainingAerobic exercise training for 12 weeks, 3 times per week, 60 minutes per session. |
| Control (standards of care) | No intervention | –This arm will receive brochures for healthy lifestyle recommendations. No intervention will be conducted. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- BMI ≥ 35 kg/m2
- Between ages 18-50 years
- Not pregnant
- Diabetic (Current use of diabetes medication or fasting glucose ≥126 mg/dL)
- Medical clearance to participate in a moderate-intensity exercise program
Key exclusion criteria (6 listed)
- Pregnant women
- Current smokers
- Currently abusing alcohol or drugs
- Chronic heart, liver, or kidney diseases, autoimmune diseases, or cancer
- Non-English speakers
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 |
|---|---|---|
| Exercise trainingAerobic exercise training using a treadmill or a bike for 12 weeks, 3 times per week, 60 minutes per session. | Other | Exercise training |
Primary outcome
Brachial artery flow-mediated dilation (percent vasodilation) in 60 obese diabetic subjects
Time frame: 4 years
Brachial flow-mediated dilation will be measured using ultrasound Alpha 7. For recording, a linear probe will be positioned five centimeters above the left arm's antecubital fossa, and a 1-minute baseline imaging will be recorded. Then, a blood pressure cuff will be put around the right mid-forearm and inflated to 200 to 220 mmHg for 5 minutes. Following cuff deflation (reactive hyperemia), a video grabber will be used to record a 300-second video sequence at three frames per second for offline measurement. The greatest brachial artery diameter at baseline will be deducted from the largest mean values obtained following cuff deflation to determine relative flow mediated dilation
1 secondary outcome
Glycosphingolipid content (ng/ml) in adiposomes from 60 obese diabetic subjects
Time frame: 4 years
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 17 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Abeer M Mohamed, MD, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Obesity and Diabetes, run by University of Illinois Chicago 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 5 inclusion and 6 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 17 Aug 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 Abeer M Mohamed, MD, PhD (312-355-8099, amahmo4@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial artery flow-mediated dilation (percent vasodilation) in 60 obese diabetic subjects (time frame: 4 years). 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 17 Aug 2026.