Exercise Training for Vascular Dysfunction in Obesity

Overseen By Abeer Mohamed, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Cancer, Heart disease, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how aerobic exercise can improve blood vessel function in people with obesity by examining changes in DNA and inflammation. Participants will be divided into two groups: one will engage in 12 weeks of aerobic exercise, while the other will maintain their usual routine without added exercise. This study is ideal for individuals with a BMI of 35 or higher who are approved for bariatric surgery. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance health outcomes for those with obesity.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that exercise training is safe for obese individuals?

Research has shown that exercise is generally safe and well-tolerated. Studies indicate that exercise can improve heart health and reduce risks linked to obesity, such as heart disease. Exercise has also enhanced blood vessel function without major safety concerns. Most participants in these studies did not experience serious side effects, suggesting that exercise is a safe way to improve health for those with obesity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exercise training for vascular dysfunction in obesity because it offers a non-pharmaceutical approach to improve vascular health. Unlike standard treatments that often rely on medications, exercise directly enhances blood flow and improves the function of blood vessels through natural means. This approach could potentially reduce the need for medications, decrease side effects, and improve overall health and well-being by promoting cardiovascular fitness and weight management.

What evidence suggests that exercise training is effective for vascular dysfunction in obesity?

This trial will compare the effects of exercise training with standard care for vascular dysfunction in obesity. Research has shown that exercise, especially activities like walking or cycling, can help manage obesity. Studies have found that it improves heart health and lowers the risk of heart disease. Exercise also aids in weight control and maintains healthy blood vessel function. Moderate-to-high-intensity exercise, such as brisk walking or jogging, can be particularly beneficial for individuals who are overweight. This type of exercise has been linked to reduced inflammation in the body, potentially leading to better overall health. ^{4 6 7 8 9}

Who Is on the Research Team?

Abeer M Mohamed, MD, PhD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for adults aged 18-50 with severe obesity (BMI ≥ 35 kg/m2) who are approved for bariatric surgery but not currently pregnant. It excludes those with cancer, heart, kidney or liver diseases, gallbladder disease, inflammatory/autoimmune conditions, smokers, and substance abusers.

Inclusion Criteria

I am approved for weight loss surgery.

BMI ≥ 35 kg/m2

Not pregnant

Exclusion Criteria

I have a current diagnosis of cancer, heart, kidney, liver, gallbladder disease, or an inflammatory/autoimmune condition.

Pregnant women

Current smokers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 12 weeks of aerobic exercise training

12 weeks

Regular visits for exercise sessions

Follow-up

Participants are monitored for changes in DNA methylation and vascular function

6 months

Weight Loss Surgery

Participants undergo bariatric surgery to assess its impact on DNA methylation and vascular function

Surgery and recovery period

What Are the Treatments Tested in This Trial?

Interventions

• Exercise training

Trial Overview The study investigates if aerobic exercise can improve blood vessel function and reduce inflammation in obese individuals by altering DNA methylation—a process affecting gene activity without changing the DNA sequence itself.

How Is the Trial Designed?

Group I: Exercising Active Control 1 Intervention

12 weeks of aerobic exercise training

Group II: Non-exercising Active Control 1 Intervention

standard of care

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Non-weight bearing all extremity high-intensity interval training (HIIT) significantly increased adiponectin levels and improved flow-mediated dilation (FMD) in overweight and obese women, suggesting cardiovascular benefits.

This 10-week HIIT program also led to reductions in weight and waist circumference, along with improvements in aerobic fitness (VO2max), making it a safe and effective exercise option for individuals unable to perform weight-bearing activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of All Extremity High Intensity Interval Training on Athero-Protective Factors and Endothelial Function in Overweight and Obese Women. Hovsepian, V., Marandi, SM., Esfarjani, F., et al.[2022]

A 12-week home-based telehealth exercise training program significantly increased physical activity levels and exercise capacity in patients with cardiometabolic multimorbidity, as shown by a randomized controlled trial involving 50 participants.

The program also improved health-related quality of life, particularly in physical function, indicating that telehealth exercise interventions can be effective and beneficial for patients managing multiple cardiometabolic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Home-Based Telehealth Exercise Training Program for Patients With Cardiometabolic Multimorbidity: A Randomized Controlled Trial. Chiang, SL., Shen, CL., Chen, LC., et al.[2021]

Obesity leads to a loss of the anti-contractile effect of perivascular adipose tissue (PVAT), which is crucial for regulating blood vessel function, contributing to conditions like hypertension and type II diabetes.

Exercise can restore the function of PVAT in obese mice by reducing inflammation and increasing the expression of important receptors, thereby reversing the negative effects of obesity on vascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restoring Perivascular Adipose Tissue Function in Obesity Using Exercise. Saxton, SN., Toms, LK., Aldous, RG., et al.[2022]

Physical inactivity significantly contributes to obesity and cardiovascular disease by causing vascular endothelial dysfunction, particularly in sedentary individuals who are also obese and insulin resistant.

Regular physical exercise, including both aerobic and resistance training, is beneficial for improving endothelial function and managing cardiovascular health, although the optimal exercise prescription and mechanisms of action are still being researched.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise interventions and peripheral arterial function: implications for cardio-metabolic disease. Phillips, SA., Mahmoud, AM., Brown, MD., et al.[2022]

Regular exercise, including both aerobic and resistance training, can significantly improve body composition and insulin sensitivity in older adults, which is crucial for managing obesity and reducing health risks.

Encouraging a physically active lifestyle in overweight and obese individuals, especially those with insulin resistance, is essential to lower the risk of cardiovascular diseases as they age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in aging: its important role in mortality, obesity and insulin resistance. Ryan, AS.[2021]

Combining exercise training with energy restriction in obese adults leads to greater improvements in cardiovascular fitness and muscle strength compared to energy restriction alone, based on a review of 14 randomized controlled trials.

Exercise training not only enhances fat loss but also helps preserve lean body mass during weight loss, highlighting the importance of incorporating exercise into lifestyle interventions for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of exercise training in addition to energy restriction on functional capacities and body composition in obese adults during weight loss: a systematic review. Miller, CT., Fraser, SF., Levinger, I., et al.[2022]

Obesity leads to dysfunction in perivascular adipose tissue (PVAT), which negatively impacts arterial health.

Exercise training has been shown to directly improve the function of PVAT, offering a new way to enhance arterial health in individuals with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Perivascular Adipose Tissue and Exercise on Arterial Function with Obesity. Boateng, SY., Olfert, IM., Chantler, PD.[2023]

Bariatric surgery is an effective treatment for morbid obesity, helping many patients achieve rapid weight loss and reduce obesity-related health issues, but some patients still face ongoing health challenges post-surgery.

Improving cardiorespiratory fitness through tailored exercise programs after bariatric surgery is crucial, as it can enhance overall health outcomes and reduce the risk of mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Exercise Mode on Improving Cardiovascular Function and Cardiorespiratory Fitness After Bariatric Surgery: A Narrative Review. Mahmoud, AM., Gonçalves da Silva, AL., André, LD., et al.[2023]

A systematic review of 10 randomized controlled trials involving 400 adults with overweight and obesity found that exercise training significantly improved endothelial function, as measured by flow-mediated dilation (FMD), compared to no exercise.

Aerobic training specifically was effective in enhancing FMD (p < 0.001), while resistance training showed no significant effect (p = 0.051), suggesting that aerobic exercise is particularly beneficial for cardiovascular health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of aerobic and resistance exercise training on endothelial function in individuals with overweight and obesity: a systematic review with meta-analysis of randomized clinical trials. Cortes, MB., da Silva, RSN., de Oliveira, PC., et al.[2023]

Cardiovascular rehabilitation significantly improves patients' physical and psychological functioning after heart-related illnesses, with benefits including enhanced exercise capacity and reduced symptoms like angina and fatigue.

Recent studies show that exercise training after a heart attack can lower the risk of mortality and major cardiac events by 20 to 25%, highlighting the importance of exercise in improving heart health and reducing future complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular rehabilitation: status, 1990. Squires, RW., Gau, GT., Miller, TD., et al.[2019]

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