Inactivity for Metabolic Diseases

Overseen By Kevin J Gries, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Concordia University Wisconsin

Disqualifiers: Cardiac, Pulmonary, Diabetes, others

Compensation: Varies

Number of Visits: 2

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how prolonged sitting affects the body's response to exercise, particularly in burning fats and carbohydrates. Participants will either spend a day being inactive (fewer than 5,000 steps) or maintain normal activity (more than 8,500 steps) before engaging in a one-hour cycling session. Researchers will collect blood and muscle samples to assess the body's response to exercise under these conditions. The study could inform guidelines to reduce the risk of heart and metabolic diseases. Individuals without serious illnesses or joint issues, who are not in a structured exercise program, and who do not smoke might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to foundational research that could enhance public health guidelines.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that prolonged sitting and inactivity can lead to health problems. Studies have found that inactivity increases the risk of heart disease, high blood pressure, obesity, and high cholesterol. These serious conditions can affect health over time.

However, this study examines short-term inactivity and its impact on exercise. It does not involve any new drugs or treatments. Participants will sit more than usual for just one day. This brief period of inactivity is not expected to cause immediate health problems for most people.

In summary, while long-term sitting can be harmful, this study involves only a short period of inactivity, which is generally safe for healthy individuals. Participants should remain aware of the health risks associated with a sedentary lifestyle outside of the study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how inactivity, rather than traditional physical activity interventions, might impact metabolic diseases. Unlike current treatments that often emphasize increasing physical activity, this trial looks at the effects of being sedentary before exercise. This unique approach could reveal important insights into optimizing exercise strategies for individuals with metabolic conditions, potentially leading to more personalized and effective treatment plans.

What evidence suggests that this trial's treatments could be effective for metabolic diseases?

This trial will compare the effects of inactivity with normal activity on metabolic health. Research has shown that prolonged sitting can harm health. One study found a link between frequent sitting and a higher risk of metabolic syndrome, a group of conditions that increase the chance of heart disease. Another study demonstrated that inactivity is a risk factor for poor heart health and early death. Even those who exercise may face higher health risks if they spend much time sitting. These findings suggest that being active might not suffice if one sits extensively during the day. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals who are interested in how a day of sitting affects muscle response to exercise and energy use during and after cycling. Participants should be able to complete one day with less than 5,000 steps followed by an hour of biking. The study requires blood samples and muscle biopsies before and after exercise.

Inclusion Criteria

I do not have any major health issues like heart, lung, liver, kidney diseases, cancer, high blood pressure, or diabetes.

I have no artificial joints and am not allergic to lidocaine.

Do not currently smoke or participate in other forms of tobacco use

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-Exercise Activity Monitoring

Participants are monitored for activity levels, either being sedentary (<5,000 steps) or maintaining normal activity (>8,500 steps) prior to exercise

1 day

1 visit (in-person)

Exercise and Sample Collection

Participants perform a 1-hour cycling exercise with blood and muscle samples collected before, during, and after exercise

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in gene expression and metabolism up to 4 hours post-exercise

4 hours

What Are the Treatments Tested in This Trial?

Interventions

• Inactivity

Trial Overview

The study investigates the impact of a sedentary day on muscles' ability to respond to aerobic exercise, specifically cycling. It measures changes in carbohydrate and fat burning during and post-exercise through blood tests and muscle tissue analysis.

How Is the Trial Designed?

Group I: Inactive Experimental Treatment 1 Intervention

Subjects will be asked to be sedentary prior to an acute exercise bout (\<5,000 steps as measured by a physical activity monitor).

Group II: Normal activity Placebo Group 1 Intervention

Subjects will be asked to have normal activity prior to an acute exercise bout (\>8,500 steps as measured by a physical activity monitor).

Who Is Running the Clinical Trial?

Concordia University Wisconsin

Lead Sponsor

Trials

5

Recruited

210+

Published Research Related to This Trial

In Germany, a significant portion of the population is affected by obesity and inactivity, with 75% of men and 59% of women aged 25-69 being overweight or obese, and 30% of all age groups being inactive, which greatly increases their risk for cardiovascular diseases.

Therapeutic lifestyle changes, including increased physical activity and dietary interventions, are crucial for reducing cardiovascular risk factors and should be prioritized for overweight or obese individuals, especially those with metabolic syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of adiposity and inactivity in primary prevention of cardiovascular disease]. König, D., Bönner, G., Berg, A.[2007]

A recent study showed that transitioning from an active lifestyle (about 10,000 steps per day) to a significantly inactive one (around 1,500 steps per day) for just 14 days led to reduced insulin sensitivity and increased central body fat in healthy young individuals.

This evidence suggests that even short-term physical inactivity can negatively impact metabolic health, highlighting the importance of maintaining regular physical activity to prevent insulin resistance and obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic disruptions induced by reduced ambulatory activity in free-living humans. Thyfault, JP., Krogh-Madsen, R.[2022]

A staggering 93.5% of the 1,253 children and adolescents studied were physically inactive, with higher rates observed in female teenagers, highlighting a significant public health concern.

The study found a significant association between the number of hours spent watching TV (≥ 3 hours) and obesity, but no correlation between physical activity levels and excess weight or body fat.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical inactivity, TV-watching hours and body composition in children and adolescents. Rivera, IR., Silva, MA., Silva, RD., et al.[2022]

Physical inactivity and low fitness in children are linked to an increased risk of cardiovascular disease (CVD) and obesity, with evidence showing that risk factors can cluster together, particularly in inactive children.

Increasing physical activity can improve metabolic health by enhancing insulin sensitivity, promoting better cholesterol ratios, and improving fat metabolism, highlighting the importance of early lifestyle interventions to prevent CVD in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mini review: physical activity and fitness and its relations to cardiovascular disease risk factors in children. Froberg, K., Andersen, LB.[2019]

Physical inactivity is a behavior that may have evolved as a protective mechanism, but it is now linked to at least 35 unhealthy conditions and is a significant contributor to the leading causes of death in the U.S.

Around 86% of the U.S. population does not meet recommended physical activity guidelines, which can lead to accelerated loss of fitness, decreased quality of life, and increased healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Inactivity in Chronic Diseases: Evolutionary Insight and Pathophysiological Mechanisms. Booth, FW., Roberts, CK., Thyfault, JP., et al.[2022]

Physical inactivity is a significant but under-researched contributor to muscle insulin resistance, which is crucial for understanding metabolic diseases.

Current rodent models primarily focus on diet-induced insulin resistance, highlighting a need for better models to study the mechanisms of physical inactivity-induced insulin resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical rodent models of physical inactivity-induced muscle insulin resistance: challenges and solutions. Reidy, PT., Monnig, JM., Pickering, CE., et al.[2022]

The Women's Lifestyle Study is a two-year randomized controlled trial aimed at increasing physical activity among 40-74 year old physically inactive women, using a nurse-led intervention that includes a 'Lifestyle script' and ongoing support through telephone counseling.

If successful, this study could be the first to show that a low-cost, evidence-based intervention can lead to sustained increases in physical activity and improvements in cardiovascular and diabetes risk factors over the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 'Women's Lifestyle Study', 2-year randomized controlled trial of physical activity counselling in primary health care: rationale and study design. Rose, SB., Lawton, BA., Elley, CR., et al.[2019]

In a study of over 2.6 million adults with type 2 diabetes, engaging in vigorous physical activity was linked to lower all-cause and cause-specific mortality over an average follow-up of 7.8 years.

The benefits of increased physical activity were particularly pronounced in patients aged 65 and older, suggesting that promoting higher activity levels could significantly reduce mortality risk in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of physical activity with total and cause-specific mortality in patients with diabetes: A nationwide population-based cohort study. Jung, I., Han, KD., Moon, SJ., et al.[2023]

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]

In a study of 2189 older adults with metabolic syndrome, higher inactive time was linked to obesity and poor metabolic health, indicating that reducing inactivity is important for better health outcomes.

Reallocating just 30 minutes of inactive time to light or moderate-to-vigorous physical activity significantly improved various health markers, including lower BMI, waist circumference, and better blood sugar levels, suggesting that even small changes in activity can have a positive impact on cardio-metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isotemporal substitution of inactive time with physical activity and time in bed: cross-sectional associations with cardiometabolic health in the PREDIMED-Plus study. Galmes-Panades, AM., Varela-Mato, V., Konieczna, J., et al.[2023]

In a study of 746 participants with recent-onset diabetes, the severe insulin-resistant diabetes (SIRD) subgroup exhibited significantly lower physical fitness levels compared to glucose-tolerant controls and other diabetes subgroups, indicating a potential link between insulin resistance and reduced physical fitness.

Despite similar endothelial function across all diabetes subgroups, the severe autoimmune diabetes (SAID) subgroup demonstrated the lowest cardiovascular risk within the first year of diagnosis, suggesting that not all diabetes types carry the same risk for cardiovascular complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Fitness and Cardiovascular Risk Factors in Novel Diabetes Subgroups. Saatmann, N., Zaharia, OP., Strassburger, K., et al.[2022]

Both obesity and low levels of physical activity are independent risk factors for health complications, meaning that each can negatively impact health on its own.

Abdominal obesity specifically predicts cardiovascular disease regardless of fitness levels, while physical activity is beneficial in reducing the risk of type 2 diabetes and heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The importance of physical activity and fitness in avoiding the complications of obesity]. Berentzen, T., Madsbad, S., Sørensen, TI., et al.[2015]

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