Lifestyle Physical Activity for Metabolic Diseases

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Houston

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Eating disorder, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to discover new methods to keep muscles active for extended periods, reducing the risks of diseases like diabetes and heart disease, particularly for those who sit for long durations. Researchers are investigating muscular exercises that can be performed for hours without causing fatigue and are easy to incorporate throughout the day. Individuals with a predominantly sedentary lifestyle who are willing to wear activity monitors may be suitable for this study. As an unphased trial, this study allows participants to contribute to innovative research that could promote healthier lifestyles for many.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications, as long as you can maintain them consistently throughout the study.

What prior data suggests that this method is safe for increasing muscle activity?

Research has shown that regular physical activity is generally safe and offers many health benefits. Studies indicate that people who exercise regularly have a lower risk of long-term illnesses like heart disease and diabetes. Exercise can also reduce the risk of early death by up to 30%. Muscle-strengthening activities can lower the risk of death from any cause by about 10-17%. These findings suggest that regular, light exercise is manageable for most people and provides significant health benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about muscular exercise for metabolic diseases because it focuses on increasing low-effort physical activity, which is different from the intense exercise regimens often recommended. Unlike medications for metabolic conditions that target symptoms with drugs, this approach leverages the body’s natural mechanisms to improve metabolic health. By promoting consistent, moderate movement, this method could be more sustainable and accessible for people, potentially leading to better long-term health outcomes.

What evidence suggests that this method is effective for metabolic diseases?

Research has shown that physical activity can significantly aid in managing metabolic diseases. This trial will focus on muscular exercise, specifically increasing low-effort muscular activity. Studies have found that aerobic exercises, such as walking or cycling, effectively improve health issues related to metabolic syndrome, including high blood sugar and insulin levels. One study discovered that regular exercise could reverse metabolic syndrome by 38%. Metabolic syndrome comprises conditions that raise the risk of heart disease and diabetes. Exercise also boosts the number of calories burned at rest and helps reduce body fat. Combining different types of exercise, like aerobic and resistance training, yields the best results for addressing metabolic syndrome. ^{6 7 8 9 10}

Who Is on the Research Team?

Marc T Hamilton, Ph.D.

Principal Investigator

University of Houston

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can fast overnight, maintain consistent diet, medication, and sleep habits. They should have a sedentary lifestyle but be willing to wear activity monitors and not start new diets or exercise programs during the study. Exclusions include practical barriers to participation, current dieting or eating disorders, allergies to lidocaine, pregnancy, use of anticoagulants, or plans to change lifestyle.

Inclusion Criteria

I can keep my diet, medications, and sleep habits consistent.

You are able to participate in a study that aims to reduce time spent being inactive.

You cannot plan to start a new diet or exercise program if you join the study.

Exclusion Criteria

I have no plans or commitments that would prevent me from completing the study.

I am taking medication that affects bleeding.

Are pregnant or plan to become pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acute Contractile Activity

Participants engage in acute contractile activity to assess immediate physiological responses

Less than 1 day

Multiple short sessions

Increased Contractile Activity

Participants increase low effort muscular activity to assess changes in metabolism and inflammation markers

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after increased contractile activity

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Muscular Exercise

Trial Overview

The trial aims to develop a method that allows people with sedentary lifestyles to sustain muscle activity via oxidative metabolism for extended periods (hours daily). It involves controlled muscular exercises focusing on specific muscles like the soleus in the leg and measuring their biological response without causing fatigue.

How Is the Trial Designed?

Group I: Muscular Exercise Experimental Treatment 1 Intervention

Increased level of low effort muscular activity

Who Is Running the Clinical Trial?

University of Houston

Lead Sponsor

Trials

155

Recruited

48,600+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Published Research Related to This Trial

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]

Skeletal muscle plays a crucial role in insulin resistance, particularly in conditions like obesity and type 2 diabetes, where it exhibits various metabolic abnormalities affecting glucose and lipid metabolism.

Exercise training has been shown to improve these muscular abnormalities and is beneficial for managing insulin resistance, but individualized exercise prescriptions are necessary due to variability in responses and conflicting results on glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin resistance and associated metabolic abnormalities in muscle: effects of exercise. Pérez-Martin, A., Raynaud, E., Mercier, J.[2019]

A qualitative study involving 20 physically inactive patients with metabolic syndrome in Gothenburg, Sweden, found that individually tailored physical activity prescriptions significantly increased and maintained physical activity levels over time.

Regular follow-ups and support from healthcare professionals, along with allowing patients to make their own choices, enhanced motivation and helped sustain lifestyle changes, leading to positive health effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailored physical activity on prescription with follow-ups improved motivation and physical activity levels. A qualitative study of a 5-year Swedish primary care intervention. Joelsson, M., Lundqvist, S., Larsson, MEH.[2021]

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 significantly reduces body weight, total body fat, and visceral fat, with a clear dose-response relationship indicating that more exercise leads to greater benefits.

Sedentary lifestyles can lead to rapid weight gain and increased visceral fat, highlighting the importance of physical activity in preventing metabolic deterioration and improving insulin signaling through enhanced fatty acid oxidation in skeletal muscle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise, abdominal obesity, skeletal muscle, and metabolic risk: evidence for a dose response. Slentz, CA., Houmard, JA., Kraus, WE.[2021]

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