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

Trial Summary

What is the purpose of this trial?

Fitness is one of the best predictors for heart and brain disease. To increase ones fitness, the American Heart Association (AHA) says to exercise at least 150 minutes per week or 75 minutes per week if really hard. These exercise guides are pretty effective, however not everyone will get the same results. What individuals do outside of the exercise bout can influence the effectiveness of exercise. One of these factors is our time sitting, which has caused the phrase "sitting is the new smoking". Other studies have said that the metabolic benefits of exercise are decreased when you exercise after a few days of low activity (less than 5,000 steps per day). This is important in that exercise may not be able to fully offset these times of inactivity. However, these studies were only looking at different fats in the blood. As exercise increases fat burn up to 10 times in the muscle, more research is needed to understand how inactivity affects the muscle during exercise and after exercise. This study will help answer two questions: 1) How does a day of sitting a lot affect the muscle's ability to respond to exercise? and 2) How does a day of sitting a lot affect carbohydrate and fat burn during and after a bout of exercise? The investigators will answer these questions by having people complete one day of inactivity (less than 5,000 steps) or normal activity (more than 8,500 steps). Subjects will then come in the next day to bike somewhat hard for 1 hour. The investigators will take blood samples before, during, and after exercise to measure energy sources. The investigators will also collect pieces of skeletal muscle before and after exercise to see how the muscle responded to exercise. This study is significant for the publication of exercise guidelines to minimize risk of heart and metabolic diseases.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Inactivity for metabolic diseases?

The research suggests that physical inactivity can lead to negative health outcomes like reduced insulin sensitivity and increased body fat, which are linked to metabolic diseases. However, there is no direct evidence supporting inactivity as an effective treatment for metabolic diseases. ^{1 2 3 4 5}

Is inactivity safe for humans?

Inactivity can lead to health issues like insulin resistance, obesity, and increased risk of heart disease and diabetes. It is generally not considered safe as it can worsen these conditions. ^{1 6 7 8 9}

How does the treatment 'Inactivity' differ from other treatments for metabolic diseases?

The treatment 'Inactivity' is unique because it focuses on the role of physical inactivity itself as a contributing factor to metabolic diseases, unlike other treatments that typically involve increasing physical activity or dietary changes. This approach highlights the impact of reduced movement on insulin resistance and obesity, offering a novel perspective on managing these conditions. ^{1 6 10 11 12}

Eligibility Criteria

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

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

Not currently in a structured exercise program

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

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

Metabolic disruptions induced by reduced ambulatory activity in free-living humans. [2022]

2. Brazil pubmed.ncbi.nlm.nih.gov

Physical inactivity, TV-watching hours and body composition in children and adolescents. [2022]

3. England 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. [2019]

4. Ireland 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. [2023]

5. 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]

6. England 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. [2023]

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

Physical Fitness and Cardiovascular Risk Factors in Novel Diabetes Subgroups. [2022]

8. Denmark pubmed.ncbi.nlm.nih.gov

[The importance of physical activity and fitness in avoiding the complications of obesity]. [2015]

9. Germany pubmed.ncbi.nlm.nih.gov

[The role of adiposity and inactivity in primary prevention of cardiovascular disease]. [2007]

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

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

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

Role of Inactivity in Chronic Diseases: Evolutionary Insight and Pathophysiological Mechanisms. [2022]

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

Preclinical rodent models of physical inactivity-induced muscle insulin resistance: challenges and solutions. [2022]