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

60 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Muscular Exercise for metabolic diseases?

Research shows that regular physical activity, including muscular exercise, can help prevent and treat metabolic diseases like type 2 diabetes and metabolic syndrome. Exercise improves heart health and reduces risk factors, even without weight loss, making it a valuable part of managing these conditions. ^{1 2 3 4 5}

Is lifestyle physical activity safe for humans?

Research shows that physical activity, including vigorous exercise, is generally safe and can lower the risk of diseases like metabolic syndrome, diabetes, and high blood pressure. It is recommended by international guidelines for people with conditions like nonalcoholic fatty liver disease. ^{6 7 8 9 10}

How does the treatment of muscular exercise differ from other treatments for metabolic diseases?

Muscular exercise is unique because it directly targets insulin resistance and improves glucose and lipid metabolism in muscles, which are key issues in metabolic diseases. Unlike medications, exercise also reduces abdominal obesity and visceral fat, offering a holistic approach to managing metabolic risk factors. ^{4 5 11 12 13}

What is the purpose of this trial?

When muscles are not contracting, the local energy demand by muscle and use of specific fuels used to produce energy by oxidative metabolism are minimal. The time people spend sitting inactive (sedentary time) typically comprises more than half of the day. This sedentary behavior is associated with elevated risk of diabetes, cardiovascular diseases, some cancers, and multiple conditions leading to poor aging. From a progressive series of experiments, the driving goal is to develop a physiological method for sustaining contractile activity via oxidative metabolism over more time than is possible by traditional exercise (hours, not minutes per day). Developing a physiological method suitable of prolonged muscular activity for ordinary people (who are often unfit) requires gaining fundamental insights about muscle biology and biomechanics. This also entails a careful appreciation of the ability to isolate specific muscles in the leg during controlled movements, such as the soleus muscle during isolated plantarflexion. This includes quantifying specific biological processes that are directly responsive to elevated skeletal muscle recruitment. The investigators will focus on movement that is safe and practical for ordinary people to do given their high amount of daily sitting time. This includes developing methods to optimally raise muscle contractile activity, in a way that is not limited by fatigue, and is feasible throughout as many minutes of the day as possible safely. This also requires development of methodologies to quantify specific muscular activity, rather than generalized body movement. There is a need to learn how much people can increase muscle metabolism by physical activity that is perceived to them as being light effort. It is important to learn if this impacts systemic metabolic processes under experimental conditions over a short term time span in order to avoid confounding influences of changes in body weight or other factors.

Research Team

Marc T Hamilton, Ph.D.

Principal Investigator

University of Houston

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

1. United States 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Associations of muscle strength and fitness with metabolic syndrome in men. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. Canada pubmed.ncbi.nlm.nih.gov

Physical activity in prevention and treatment of the metabolic syndrome. [2022]

5. Czech Republic pubmed.ncbi.nlm.nih.gov

[Exercise therapy for patients with metabolic syndrome]. [2017]

6. Brazil pubmed.ncbi.nlm.nih.gov

Physical activity as a protective factor for development of non-alcoholic fatty liver in men. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Association of Physical Activity With Risk of Liver Fibrosis, Sarcopenia, and Cardiovascular Disease in Nonalcoholic Fatty Liver Disease. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Contribution of sarcopenia and physical inactivity to mortality in people with non-alcoholic fatty liver disease. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Vigorous physical activity provides protection against all-cause deaths among adults patients with nonalcoholic fatty liver disease (NAFLD). [2023]

10. England pubmed.ncbi.nlm.nih.gov

Relationship of "weekend warrior" and regular physical activity patterns with metabolic syndrome and its associated diseases among Chinese rural adults. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Exercise, abdominal obesity, skeletal muscle, and metabolic risk: evidence for a dose response. [2021]

12. Czech Republic pubmed.ncbi.nlm.nih.gov

[Locomotive activity in prevention blood-vessel complication and diabetes]. [2017]

13. England pubmed.ncbi.nlm.nih.gov

Insulin resistance and associated metabolic abnormalities in muscle: effects of exercise. [2019]