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Exercise Training for Cardiovascular Disease

N/A
Recruiting
Led By Abeer M Mohamed, MD, PhD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diabetic (Current use of diabetes medication or fasting glucose ≥126 mg/dL)
BMI ≥ 35 kg/m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial is investigating the role of glycosphingolipids (GSLs) in the development of type II diabetes and cardiovascular disease. They will test the hypotheses that exercise and weight loss interventions will reduce the levels of GSLs in obese diabetic patients and alleviate vascular risk.

Who is the study for?
This trial is for adults aged 18-50 with obesity (BMI ≥ 35 kg/m2) and type II diabetes, who are not pregnant, can exercise moderately, and have no chronic heart, liver, kidney diseases or cancer. Smokers, drug/alcohol abusers, non-English speakers and those allergic to lidocaine cannot join.Check my eligibility
What is being tested?
The study investigates how fat cells in obese diabetic patients affect blood vessel function by releasing 'adiposomes' that may carry harmful lipids. It will test if exercise training or weight loss surgery can reduce these effects and improve vascular health.See study design
What are the potential side effects?
Since the intervention involves moderate-intensity exercise training and potentially bariatric surgery for weight loss, side effects might include typical post-exercise soreness or surgical risks such as infection or complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am diabetic or my fasting blood sugar is 126 mg/dL or higher.
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My BMI is 35 or higher.
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I am between 18 and 50 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brachial artery flow-mediated dilation (percent vasodilation) in 60 obese diabetic subjects
Secondary outcome measures
Glycosphingolipid content (ng/ml) in adiposomes from 60 obese diabetic subjects

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise trainingExperimental Treatment1 Intervention
Aerobic exercise training for 12 weeks, 3 times per week, 60 minutes per session.
Group II: Control (standards of care)Active Control1 Intervention
This arm will receive brochures for healthy lifestyle recommendations. No intervention will be conducted.

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
609 Previous Clinical Trials
1,559,249 Total Patients Enrolled
2 Trials studying Diabetes
3,762 Patients Enrolled for Diabetes
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,567 Total Patients Enrolled
28 Trials studying Diabetes
51,760 Patients Enrolled for Diabetes
Abeer M Mohamed, MD, PhDPrincipal InvestigatorUniversity of Illinois at Chicago

Media Library

Exercise training Clinical Trial Eligibility Overview. Trial Name: NCT05199454 — N/A
Diabetes Research Study Groups: Control (standards of care), Exercise training
Diabetes Clinical Trial 2023: Exercise training Highlights & Side Effects. Trial Name: NCT05199454 — N/A
Exercise training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05199454 — N/A
Diabetes Patient Testimony for trial: Trial Name: NCT05199454 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently engaged in this experiment?

"Affirmative. According to the clinicaltrials.gov database, this study is still actively searching for participants and has been since May 16th of 2022; its most recent edit was on October 25th 2022. 60 patients will be accepted from a single site."

Answered by AI

Are participants being recruited for this experiment presently?

"Indeed, the records on clinicaltrials.gov support that this research is currently recruiting participants. The trial was first initiated on May 16th 2022 and its most recent update occurred in October 25th 2022. This study requires 60 people to be recruited from a single site location."

Answered by AI

Could I qualify to be part of this clinical research?

"The team behind this study is currently seeking 60 individuals aged 18 to 50 who suffer from obesity. All participants should have a BMI of at least 35 kg/m2, be cleared by their physician for moderate exercise, and not pregnant."

Answered by AI

Are individuals aged 25 years or older allowed to participate in this trial?

"The parameters for selection into this medical trial are between 18 and 50 years of age. Conversely, there exist 239 trials catered to minors under the legal age and 1079 studies designed specifically for senior citizens."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
What site did they apply to?
University of Illinois at Chicago
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
2

Why did patients apply to this trial?

I NEED TO PROLONG MY LIFE WITH THESE 3 MAIN MEDICAL PROBLEMES. I have been on a continual weight loss journey over the past 20 years. It's like a roller coaster ride. Lose 50, gain it back. Lose 60 gain it back. Both times without medication. Just a weight-loss plan.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Role of Adiposomes in Endothelial Dysfunction
Abeer M. Mohamed 2022. "Role of Adiposomes in Endothelial Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05199454.
~35 spots leftby Dec 2026
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