Weight Loss and Exercise for Insulin Resistance in Aging

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Translational Research Institute for Metabolism and Diabetes, Florida

Disqualifiers: Cardiovascular disease, Peripheral vascular, Hepatic, others

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

Compensation: Varies

Number of Visits: 2

Duration: 6 months

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to provide information regarding potential factors underlying metabolic dysfunction, insulin resistance, and loss of muscle mass in aging muscle.

Will I have to stop taking my current medications?

If you have diabetes, you will need to stop taking your diabetes medication for 14 days before the trial starts. This is called a washout period. For other medications, the trial protocol does not specify if you need to stop taking them.

What data supports the effectiveness of the treatment Energy Restriction-Induced Weight Loss, Exercise, Physical Activity, Workout, Fitness Training for insulin resistance in aging?

Research shows that combining exercise with an energy-restricted diet leads to greater weight loss compared to exercise alone, which can help improve insulin resistance. Additionally, high levels of physical activity are essential for maintaining weight loss, which is important for managing insulin resistance. ^{1 2 3 4 5}

Is weight loss and exercise safe for humans?

Research shows that weight loss through diet and exercise is generally safe for humans, including older adults and obese individuals. These interventions are often used to improve health conditions like insulin sensitivity and cardiometabolic risk, with no significant safety concerns reported in the studies. ^{2 4 6 7 8}

How does the treatment of energy restriction-induced weight loss and exercise differ from other treatments for insulin resistance in aging?

This treatment combines calorie restriction with exercise to improve insulin sensitivity, which may offer more benefits than either approach alone. Unlike some treatments that focus solely on medication or diet, this approach emphasizes lifestyle changes that can enhance physical fitness and potentially reverse some age-related insulin resistance. ^{2 3 9 10 11}

Research Team

Bret Goodpaster, PhD

Principal Investigator

Translational Research Institute for Metabolism and Diabetes

Eligibility Criteria

The MIRAGE study is for older adults aged 65-80 who are overweight, sedentary, non-smokers with stable weight and blood pressure within certain limits. Those with diabetes must be able to monitor their own blood sugar after stopping medication for two weeks. People with recent heart attacks, vascular diseases, neuropathy or serious liver, kidney or muscle conditions cannot join.

Inclusion Criteria

Your blood pressure should be below 150/95 mmHg when measured at rest.

Your weight has not changed by more than 10 pounds in the past 6 months.

You do not engage in regular exercise, meaning you do not exercise at least once a week.

Exclusion Criteria

I do not have active liver, kidney, muscle, or blood cancer conditions.

Weak pulse that a doctor can feel

You have abnormal sounds in your legs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurements of muscle strength and power using a short physical performance battery, knee extension, and muscle power testing

1 day

Visit 2 (baseline)

Treatment

Participants undergo diet-induced weight loss with or without exercise to study effects on mitochondrial biogenesis, cellular redox state, and insulin resistance

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including insulin sensitivity and intramyocellular lipid measurements

4 weeks

Treatment Details

Interventions

• Energy Restriction-Induced Weight Loss
• Exercise

Trial Overview This trial investigates how energy restriction-induced weight loss and exercise can affect insulin resistance and muscle mass in aging individuals. It aims to uncover factors contributing to metabolic dysfunction in the elderly.

Participant Groups

Group I: Exercise training protocol Experimental Treatment 1 Intervention

Group II: Energy restriction-induced weight loss Experimental Treatment 1 Intervention

Group III: Health Education Active Control 1 Intervention

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+

Findings from Research

Most randomized controlled trials (RCTs) show that exercise alone leads to only modest weight loss, and while combining exercise with dietary restriction can enhance weight loss, the energy deficit from exercise is often much smaller than that from diet alone.

High levels of exercise can lead to significant weight loss comparable to caloric restriction, but maintaining such exercise levels can be challenging for overweight or obese individuals, highlighting the importance of physical activity for long-term weight maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of physical activity in producing and maintaining weight loss. Catenacci, VA., Wyatt, HR.[2022]

Combining physical exercise with energy restriction diets leads to greater weight loss than exercise alone, making it the most effective strategy for significant weight loss.

Engaging in at least 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity aerobic exercise weekly, along with resistance training, is recommended for weight loss and maintenance, which also helps improve obesity-related health issues like diabetes and cardiovascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity and physical exercise. Celik, O., Yildiz, BO.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Fitness, Strength and Body Composition during Weight Loss in Women with Clinically Severe Obesity: A Randomised Clinical Trial. [2021]

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

Short-term moderate weight loss and resistance training do not affect insulin-stimulated glucose disposal in postmenopausal women. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The role of physical activity in producing and maintaining weight loss. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

Obesity and physical exercise. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Calorie restriction in overweight older adults: Do benefits exceed potential risks? [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Individual Response Variation in the Effects of Weight Loss and Exercise on Insulin Sensitivity and Cardiometabolic Risk in Older Adults. [2021]

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

Energy balance during an 8-wk energy-restricted diet with and without exercise in obese women. [2018]

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

Independent and additive effects of energy restriction and exercise on glucose and insulin concentrations in sedentary overweight men. [2023]

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

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

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

Calorie Restriction and Matched Weight Loss From Exercise: Independent and Additive Effects on Glucoregulation and the Incretin System in Overweight Women and Men. [2023]

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

The impact of exercise training compared to caloric restriction on hepatic and peripheral insulin resistance in obesity. [2021]