Exercise for Metabolic Disorders

(Columbus Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Translational Research Institute for Metabolism and Diabetes, Florida

Must not be taking: Weight loss drugs, Blood thinners

Disqualifiers: Type 2 diabetes, Significant disease, Smoking, Pregnancy, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how exercise influences metabolic disorders by examining proteins and genetic factors released during physical activity. Researchers will divide participants into three groups: those following a regular exercise routine, athletes maintaining their workout habits, and individuals with obesity who will not exercise. The trial is ideal for people aged 18-40 who can abstain from alcohol and caffeine before blood tests. Those not currently exercising regularly but willing to start, as well as athletes or individuals with obesity, might be a good fit. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research on exercise and metabolic health.

Will I have to stop taking my current medications?

The trial requires that you stop taking any drugs known to affect energy metabolism or body weight, such as orlistat or ephedrine. If you are on blood thinners or anti-platelet medications, you must be able to safely stop them for testing procedures.

What prior data suggests that exercise is safe for metabolic disorders?

Research shows that exercise is generally safe and offers many health benefits. Studies have found that regular physical activity can significantly lower the risk of chronic diseases. For instance, it can reduce the risk of heart disease by 80% and type 2 diabetes by 90%. Exercise also improves fitness, controls blood sugar, and manages cholesterol levels.

Most people handle exercise well, and problems are rare when done correctly. Following guidelines is important to avoid risks like injuries. Before starting a new exercise routine, consulting a healthcare provider is wise, especially for those with existing health issues. Overall, exercise is a safe and effective way to boost health and prevent disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the exercise protocol for metabolic disorders because it offers a natural, drug-free approach to managing these conditions. Unlike standard treatments that often rely on medications like metformin or insulin, this protocol emphasizes the benefits of physical activity, specifically combining interval and aerobic training. This approach can help improve metabolic health without the side effects associated with pharmaceuticals. Additionally, by focusing on exercise, the protocol could potentially enhance overall well-being, including cardiovascular and mental health, making it a holistic option for individuals with metabolic disorders.

What evidence suggests that exercise is effective for metabolic disorders?

This trial will compare different exercise regimens and their effects on metabolic health. Studies have shown that exercise effectively improves metabolic health. Research indicates that regular physical activity enhances the body's ability to use oxygen during exercise, leading to better fitness and improved control of blood sugar and cholesterol levels. One study found that aerobic exercise significantly lowered insulin levels and HbA1c, a measure of blood sugar control. Exercise also improved insulin management and reduced risk factors for metabolic disorders. Overall, these findings demonstrate that exercise plays a crucial role in managing and improving metabolic health. ^{1 6 7 8 9}

Who Is on the Research Team?

Steven R Smith, MD

Principal Investigator

Translational Research Institute for Metabolism and Diabetes

Are You a Good Fit for This Trial?

This trial is for healthy men and women aged 18-40 who don't have Type 2 Diabetes or significant diseases affecting the kidneys, heart, liver, lungs, or nerves. Participants must not use certain weight-affecting drugs and should be free from recent surgeries or conditions that affect blood flow. They can't smoke or consume alcohol/caffeine before tests.

Inclusion Criteria

Willing to stop alcohol and caffeine consumption for 48 hours preceding each blood draw

Exclusion Criteria

Abnormal resting ECG

Unwilling or unable to abstain from caffeine or alcohol 48 hours prior to metabolic rate measurements

Metal objects that would interfere with the measurement of body composition /magnetic resonance spectroscopy such as implanted rods, surgical clips, etc

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Initial assessments including muscle biopsy and blood plasma samples

1 week

1 visit (in-person)

Exercise Intervention

Participants undergo alternate interval training and aerobic training

3 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for changes in mitochondrial capacity and protein expression

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Exercise

Trial Overview The study aims to identify muscle-secreted factors that contribute to exercise's benefits by analyzing participants' responses to physical activity. Researchers will look for proteins and genetic markers linked with improved lipid oxidation.

How Is the Trial Designed?

Group I: Group 1 - Regular exercise Experimental Treatment 1 Intervention

Alternate interval training and aerobic training and exercise

Group II: Group 2 - Athlete exercise Active Control 1 Intervention

Athletes are not given any intervention

Group III: Group 3 - Obese No Exercise Active Control 1 Intervention

The Obese group will not receive intervention

Who Is Running the Clinical Trial?

Translational Research Institute for Metabolism and Diabetes, Florida

Lead Sponsor

Trials

41

Recruited

3,600+

AdventHealth Translational Research Institute

Lead Sponsor

Trials

51

Recruited

5,900+

Sanford-Burnham Medical Research Institute

Collaborator

Trials

9

Recruited

770+

Takeda

Industry Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Published Research Related to This Trial

Exercise training significantly improves insulin sensitivity, glucose tolerance, and lowers triglyceride and cholesterol levels in nondiabetic, nonobese individuals with hypertriglyceridemia, but these benefits are not observed in patients with impaired glucose tolerance.

In severely obese individuals without diabetes, combining exercise with a calorie-restricted diet enhances insulin sensitivity, while in obese patients with non-insulin dependent diabetes, adding exercise to sulfonylurea therapy improves insulin sensitivity and reduces glucose levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise training on glucose control, lipid metabolism, and insulin sensitivity in hypertriglyceridemia and non-insulin dependent diabetes mellitus. Lampman, RM., Schteingart, DE.[2007]

In a randomized controlled trial involving 209 elderly participants (average age 80), a home-based exercise program was found to be generally safe, with 151 adverse events reported, affecting 47% of participants.

Despite the program's safety, 14% of the adverse events were serious, highlighting that high levels of pre-existing morbidity in this population can pose challenges to maintaining consistent exercise participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. Hinrichs, T., Bücker, B., Wilm, S., et al.[2015]

Physical activity is crucial for preventing and managing type 2 diabetes and cardiovascular risks, but individuals with diabetes face higher risks of injury during exercise due to complications associated with the disease.

To ensure safe exercise for people with type 2 diabetes, it is important to tailor exercise programs to individual health conditions and complications, such as diabetic foot and retinopathy, while implementing preventative measures to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of exercise-related injuries and adverse events in patients with type 2 diabetes. Mendes, R., Sousa, N., Reis, VM., et al.[2013]

Researchers in resistance training studies often lack clear guidance and motivation for thorough adverse event (AE) reporting, which can lead to inconsistent practices.

There is a need for exercise-specific guidelines for AE reporting, as current standards are perceived as not applicable to exercise trials, highlighting the importance of tailored strategies to improve reporting consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2022]

In a 1.5-year study involving 274 male veterans with cardiovascular disease risk factors, only one serious adverse event (atrial fibrillation) occurred, indicating that a progressive walking program can be safely recommended for high-risk individuals.

While minor musculoskeletal issues were common, over half of the reported adverse events were unrelated to the exercise program, highlighting the need for strategies to help individuals with chronic illnesses safely resume physical activity after any health setbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. Goodrich, DE., Larkin, AR., Lowery, JC., et al.[2022]

A study involving 24 patients with metabolic syndrome revealed that while most patients understand the benefits of physical activity, 62% were unaware of the specific recommendations from health authorities to exercise for half an hour daily at medium intensity.

Despite 87% of patients expressing motivation to increase their physical activity, many faced barriers such as lack of opportunities and guidance, highlighting the need for better communication of exercise recommendations and practical support for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity behaviour in patients with metabolic syndrome. Murer, M., Schmied, C., Battegay, E., et al.[2022]

Exercise training (ET) for 9 months significantly improved metabolic parameters, such as hemoglobin A1c and measures of body fat, in participants with type 2 diabetes, regardless of whether they improved their cardiorespiratory fitness (CRF).

Both fitness responders and nonresponders experienced similar benefits in metabolic health, indicating that ET can be effective even for those who do not show significant increases in cardiorespiratory fitness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic Effects of Exercise Training Among Fitness-Nonresponsive Patients With Type 2 Diabetes: The HART-D Study. Pandey, A., Swift, DL., McGuire, DK., et al.[2022]

Exercise plays a crucial role in preventing and treating cardiovascular disease (CVD), type 2 diabetes (T2D), and metabolic syndrome, supported by numerous observational and intervention studies.

Both aerobic and resistance exercises provide significant health benefits and improve risk markers for CVD and T2D, regardless of weight loss, highlighting the importance of incorporating various types of physical activity into exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for prevention and treatment of cardiovascular disease, type 2 diabetes, and metabolic syndrome. Gaesser, GA.[2022]

Regular exercise has been shown to effectively reduce abdominal obesity and improve body composition, which are key factors in managing metabolic syndrome, a condition affecting over 20% of adults globally.

There is moderate evidence supporting exercise programs as a treatment for metabolic syndrome, but the optimal type and amount of exercise needed for the best results is still unclear, highlighting the challenge of ensuring individuals stick to these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abdominal obesity and metabolic syndrome: exercise as medicine? Paley, CA., Johnson, MI.[2022]

A systematic review of four randomized controlled trials involving 428 participants suggests that goal setting may improve adherence to physical activity recommendations for people with metabolic syndrome over three to six months, although the evidence is of very low certainty.

Self-monitoring and feedback strategies showed low certainty evidence of increasing adherence to physical activity interventions over 12 months, indicating that these behavior change techniques could be beneficial for managing metabolic syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior Change Techniques Improve Adherence to Physical Activity Recommendations for Adults with Metabolic Syndrome: A Systematic Review. Peiris, CL., Gallagher, A., Taylor, NF., et al.[2023]

Regular physical activity leads to significant metabolic and cardiovascular adaptations that can improve insulin resistance, which is crucial for managing metabolic syndrome.

Patient motivation and adherence to exercise therapy are essential for achieving positive treatment outcomes in individuals with metabolic syndrome, highlighting the need for a comprehensive approach to therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Exercise therapy for patients with metabolic syndrome]. Svacinová, H.[2017]

A systematic review of 11 studies involving 156 clinically stable patients with cardiometabolic diseases found that high-intensity interval exercise (HIIE) can lead to adverse responses in about 8% of individuals, indicating a higher risk compared to moderate-intensity exercise.

It is recommended that patients with cardiometabolic diseases who wish to engage in HIIE should be clinically stable, have prior experience with moderate-intensity exercise, and exercise under supervision to ensure safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Doesn't Kill You Makes You Fitter: A Systematic Review of High-Intensity Interval Exercise for Patients with Cardiovascular and Metabolic Diseases. Levinger, I., Shaw, CS., Stepto, NK., et al.[2022]

Structured endurance exercise can significantly improve glycemic control, insulin sensitivity, and cardiovascular risk factors in individuals with Type 2 diabetes, showing effects comparable to standard medications.

While exercise is beneficial, adherence to structured programs can be challenging, and more research is needed to understand the impact of lifestyle-based physical activity and the specific types and amounts of exercise that are most effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revisiting the role of physical activity and exercise in the treatment of type 2 diabetes. Tudor-Locke, CE., Bell, RC., Meyers, AM.[2019]

Citations

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Physical activity in metabolic syndrome - PMC Early implementation of exercise leads to improved physical fitness, better glycemic control and lipid profile. Undertaking systematic PA is associated with ...

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A Systematic Review with Meta-Analysis of Clinical Trials There is well-established evidence that aerobic exercise significantly enhances aerobic capacity, which is positively associated with ...

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Physical activity, exercise, and chronic diseases: A brief review The implementation of daily PA and exercise prevention interventions support an 80% reduction in CVD risk, 90% reduction in type 2 diabetes risk, 33% reduction ...

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Physical activity in metabolic syndrome Early implementation of exercise leads to improved physical fitness, better glycemic control and lipid profile. Undertaking systematic PA is associated with ...

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Benefits of Physical Activity Regular physical activity can reduce your risk of developing type 2 diabetes and metabolic syndrome. Metabolic syndrome is some combination ...

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Epidemiology and Cardiovascular Benefits of Physical ... Studies from elite athletes suggest that endurance athletes have improved cardiovascular health in older age than former athletes who trained in ...