Exercise Training for Metabolic Health in Aging

(BATSR Trial)

Overseen By Recruitment Department

Age: 65+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Translational Research Institute for Metabolism and Diabetes, Florida

Must not be taking: Anti-inflammatories, Corticosteroids, Anabolic agents, others

Disqualifiers: Diabetes, Hypertension, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 4

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to define the effect of aging on brown adipose tissue mass in a cohort of older sedentary and older athlete adults.

Will I have to stop taking my current medications?

The trial requires participants to stop taking medications, dietary supplements, or substances that could affect glucose metabolism, are considered anabolic, or aid in weight loss starting two weeks before and throughout the study. However, if you are on stable doses of medications for blood pressure, cholesterol, or GERD, you may be allowed to continue them.

Is exercise training generally safe for humans?

Exercise training, including resistance training, is generally safe for humans and is associated with various health benefits, such as improved muscle strength, reduced risk of metabolic disorders, and better glucose metabolism. Regular physical activity can also lower the risk of developing conditions like diabetes and cardiovascular diseases. ^{1 2 3 4 5}

How does exercise training differ from other treatments for metabolic health in aging?

Exercise training is unique because it naturally improves metabolic health by increasing muscle insulin sensitivity and reducing abdominal fat, which are key factors in preventing insulin resistance and type 2 diabetes. Unlike medications, it also enhances muscle function and cardiovascular health without the need for drugs. ^{4 6 7 8 9}

What data supports the effectiveness of the treatment Exercise Training for Metabolic Health in Aging?

Research shows that regular exercise can improve insulin sensitivity and glucose tolerance, which are important for metabolic health, especially in older adults. Studies indicate that exercise helps reduce insulin resistance and improve glucose control, which are beneficial for managing conditions like type 2 diabetes. ^{4 6 7 8 10}

Who Is on the Research Team?

Paul Coen, PhD

Principal Investigator

Study Principal Investigator

Are You a Good Fit for This Trial?

The BATSR trial is for men and women aged 65-90 with stable weight, non-smokers, not on certain medications or pursuing weight loss. They must have specific cholesterol levels, normal kidney function (eGFR > 45), a BMI up to 35kg/m2, no recent significant weight changes, and be able to follow the study protocol.

Inclusion Criteria

My kidney function is good, with an eGFR over 45.

BMI 35kg/m2, inclusive at time of screening.

I have not smoked or used nicotine products, including vapes, in the last 3 months.

Exclusion Criteria

I cannot undergo MRI or DEXA scans due to physical size, claustrophobia, or doctor's advice.

My medication for blood pressure, cholesterol, or GERD has been stable for the last 30 days.

I have a chronic infectious disease like TB, Hepatitis B/C, or HIV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of brown adipose tissue mass and metabolic function

1 week

Observation

Participants are observed for changes in brown adipose tissue mass and metabolic function

8 weeks

4 days per week, 30 minutes

Follow-up

Participants are monitored for safety and effectiveness after the observation period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dual Energy X-Ray Absorptiometry (DEXA)
• Exercise Training Intervention
• Handgrip strength test
• Hyperinsulinemic-euglycemic clamp
• Lower extremity performance battery
• MRI
• Post-Intervention Testing
• Resting Metabolic Rate/Respiratory Quotient (RMR/RQ)
• Step Test
• V02 max test/stress test

Trial Overview This study tests how exercise affects brown adipose tissue in older adults. Participants will engage in an exercise training intervention designed to assess changes in metabolic and cardiac health related to aging.

How Is the Trial Designed?

Group I: OA- Older Athlete Active Control 1 Intervention

Older adults who are regularly engaged in endurance exercise

Group II: OS- Older Sedentary Active Control 1 Intervention

Older adults who are sedentary

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+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A 24-week moderate exercise program (60 minutes, 3 days a week) significantly improved aerobic capacity in 14 sedentary elderly males, indicating that regular exercise can enhance physical fitness in older adults.

The training also led to a reduction in serum α-MSH and thyroid hormones (T3 and T4) after 6 months, suggesting that moderate exercise positively influences metabolic profiles and hormonal balance in the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic exercise promotes alterations in the neuroendocrine profile of elderly people. Alves, ES., Souza, HS., Rosa, JP., et al.[2012]

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]

Regular physical activity significantly reduces the risk of developing impaired glucose tolerance and non-insulin-dependent diabetes mellitus (NIDDM), especially in individuals at high risk, as supported by various epidemiological and aging studies.

Exercise training, particularly vigorous and prolonged protocols, can improve insulin sensitivity and glucose tolerance by increasing muscle insulin action and promoting beneficial changes in muscle morphology, such as increased capillary density and the conversion of muscle fiber types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of exercise training in the prevention and treatment of insulin resistance and non-insulin-dependent diabetes mellitus. Ivy, JL.[2022]

Resistance training (RT) is the only non-drug method proven to effectively counteract age-related declines in muscle mass, strength, and power, while also reducing risks of various health issues like cardiovascular disease and depression.

Minimal-dose RT strategies, which involve lower training volumes and can be performed with minimal equipment, are effective in improving strength and functional ability, making it easier for more people to participate and potentially enhancing overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal-Dose Resistance Training for Improving Muscle Mass, Strength, and Function: A Narrative Review of Current Evidence and Practical Considerations. Fyfe, JJ., Hamilton, DL., Daly, RM.[2022]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

Chronic exercise promotes alterations in the neuroendocrine profile of elderly people. [2012]

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

Metabolic Effects of Exercise Training Among Fitness-Nonresponsive Patients With Type 2 Diabetes: The HART-D Study. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Role of exercise training in the prevention and treatment of insulin resistance and non-insulin-dependent diabetes mellitus. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of High-Intensity Power Training on Habitual, Intervention and Total Physical Activity Levels in Older Adults with Type 2 Diabetes: Secondary Outcomes of the GREAT2DO Randomized Controlled Trial. [2021]

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

Effect of physical training on the insulin resistance of aging. [2017]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Physically active vs. inactive lifestyle, muscle properties, and glucose homeostasis in middle-aged and older twins. [2022]

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

Sex differences in the response to resistance exercise training in older people. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Minimal-Dose Resistance Training for Improving Muscle Mass, Strength, and Function: A Narrative Review of Current Evidence and Practical Considerations. [2022]

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

Short-term effects of repetitive arm work and dynamic exercise on glucose metabolism and insulin sensitivity. [2013]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Strength training improves insulin resistance and differently affects mitochondria in skeletal muscle and visceral adipose tissue in high-fat fed mice. [2021]