Removal of Exercise for Impaired Glucose Tolerance

Overseen By Leryn Reynolds

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Old Dominion University

Must not be taking: Blood glucose medications

Disqualifiers: HIV, Hepatitis, Tuberculosis, Smoking, others

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

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine if an acute bout of removal of exercise reduces enothelial function and glycemic control in an active, older adult population; and whether a 3 day return to exercise restores this response. Glycemic control is the blood glucose response following the consumption of a meal. It is an indicator of insulin resistance (or type 2 diabetes) and impaired glycemic control has been suggested to lead to cardiovascular disease. Endothelial function has been shown to be improved by chronic or acute increases in physical activity. Both of these have been shown to be impaired to acute bouts of inactivity in young populations; however the impact of acute inactivity in older adults is less understood. In this proposal the investigators will examine 1)how quickly impairments in glycemic control occur to acute physical inactivity in older adults who exercise, 2) how quickly impairments in endothelial function occur to acute inactivity in older adults who exercise, and 3) whether 3 days of a return to exercise restores these responses.

Will I have to stop taking my current medications?

Yes, you will need to stop taking medications that alter blood glucose levels to participate in this trial.

Is it safe to remove exercise for people with impaired glucose tolerance?

The research does not provide specific safety data on removing exercise for people with impaired glucose tolerance. However, exercise is generally considered beneficial for managing glucose levels and reducing the risk of diabetes-related complications. ^{1 2 3 4 5}

How does the removal of exercise as a treatment for impaired glucose tolerance differ from other treatments?

This treatment is unique because it involves removing exercise, which is typically recommended to improve glucose tolerance and prevent type 2 diabetes. Unlike other treatments that emphasize physical activity to enhance insulin sensitivity, this approach explores the effects of not exercising on glucose tolerance. ^{1 4 5 6 7}

Eligibility Criteria

This trial is for healthy, physically active older adults aged 55 and above who currently exercise at least 90 minutes per week. It's also open to those between 18-40 years old. Participants should not have physical limitations that could affect changes in their daily activity levels.

Inclusion Criteria

Healthy, physically active, performing at least 90 min/week of physical activity

I am either 55 years or older, or between 18 and 40 years old.

I don't have physical limitations affecting my daily activities.

Exclusion Criteria

Body weight change of greater than 5% within the previous 2 months

Smoking within the previous 2 months

I have been diagnosed with HIV, hepatitis, or tuberculosis by a doctor.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Phase (EX)

Participants perform their normal exercise routines while having their blood vessel health and blood glucose levels measured.

3 days

Continuous monitoring

No Exercise Phase (NOEX)

Participants undergo 1, 3, or 5 days of no exercise to assess impairments in glycemic control and endothelial function.

1-5 days

Continuous monitoring

Return to Exercise Phase (REX)

Participants return to exercise for 1 to 3 days to assess restoration of glycemic control and endothelial function.

1-3 days

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after the intervention phases.

4 weeks

Treatment Details

Interventions

• Removal of Exercise

Trial Overview The study aims to see if stopping exercise briefly affects blood sugar control and blood vessel health in older adults who usually stay active. Researchers will check how fast these effects happen with no exercise, and if going back to exercising for three days can reverse any negative impacts.

Participant Groups

Group I: Vascular Experimental Treatment 1 Intervention

Vascular: Participants will have their blood vessel health measured while performing their normal exercise routines (EX) and while undergoing 1, 3, 5 days of no exercise (NOEX) followed immediately by 1 and 3 days of return to exercise (REX).

Group II: Metabolic Experimental Treatment 1 Intervention

Metabolic: Participants will have their blood glucose levels measured via continuous glucose monitoring for 3 days while participating in their normal exercise routines (EX). Participants will also have their blood glucose levels measured for 3 days while not exercising (NOEX), following immediately by 3 days of a return to normal activity(REX). Participants will be randomized to participate in the EX or NOEX/REX phases first. The EX and NOEX/REX phases will be separated by at least 1 week

Who Is Running the Clinical Trial?

Old Dominion University

Lead Sponsor

Trials

25

Recruited

15,500+

Findings from Research

In a study of 92 patients with type 2 diabetes, higher volumes of exercise were linked to increased odds of discontinuing glucose-lowering medications, with the highest exercise group showing an odds ratio of 34.4 compared to standard care.

Significant improvements in cardiovascular risk factors, such as glycated hemoglobin and triglyceride levels, were observed in patients who exercised more, particularly in the intermediate and upper exercise tertiles, indicating that exercise can enhance overall health in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-Response Effects of Exercise on Glucose-Lowering Medications for Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial. MacDonald, CS., Johansen, MY., Nielsen, SM., et al.[2022]

Physical activity is crucial for preventing and managing type 2 diabetes and cardiovascular risks, but individuals with diabetes face higher risks of injury during exercise due to complications associated with the disease.

To ensure safe exercise for people with type 2 diabetes, it is important to tailor exercise programs to individual health conditions and complications, such as diabetic foot and retinopathy, while implementing preventative measures to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of exercise-related injuries and adverse events in patients with type 2 diabetes. Mendes, R., Sousa, N., Reis, VM., et al.[2013]

Exercise can greatly benefit people with diabetes, but it's crucial to measure glucose levels before starting to ensure safety during workouts.

Guidelines have been developed to help exercise specialists determine when to start or stop exercise based on glucose levels, with specific contraindications such as low glucose (<4.0 mmol/L) or high glucose (>15.0 mmol/L with symptoms).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resources to Guide Exercise Specialists Managing Adults with Diabetes. Turner, G., Quigg, S., Davoren, P., et al.[2020]

A systematic review of 5 randomized controlled trials involving 549 participants found that structured exercise interventions can lead to significant improvements in physical activity levels and body composition shortly after the intervention, but these benefits may not be sustained long-term.

Only one of the studies showed lasting improvements in physical activity levels up to 5 years post-intervention, highlighting the need for further research on how to maintain increased physical activity after structured exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Physical Activity Levels After the End of a Structured Exercise Intervention in Adults With Type 2 Diabetes and Prediabetes: A Systematic Review. Booth, JE., Benham, JL., Schinbein, LE., et al.[2021]

Physical inactivity is a significant risk factor for impaired glucose tolerance (IGT), insulin resistance, and type 2 diabetes, highlighting the importance of regular physical activity in preventing these conditions.

Regular exercise training improves insulin action and glucose tolerance in individuals at risk for type 2 diabetes, making it an effective therapeutic intervention to combat insulin resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise as a therapeutic intervention for the prevention and treatment of insulin resistance. Hawley, JA.[2006]

Regular vigorous exercise can prevent the decline in glucose tolerance and insulin sensitivity associated with aging, and may completely normalize glucose tolerance in some patients with mild non-insulin dependent diabetes mellitus (NIDDM) and impaired glucose tolerance (IGT).

To achieve normalization of glucose tolerance, patients need to engage in approximately 25 to 35 kilometers of running or an equivalent amount of other vigorous exercise each week, particularly if they still have the ability to secrete insulin and insulin resistance is the main issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise on glucose tolerance and insulin resistance. Brief review and some preliminary results. Holloszy, JO., Schultz, J., Kusnierkiewicz, J., et al.[2019]

Impaired glucose tolerance (IGT) significantly increases the risk of developing non-insulin-dependent diabetes mellitus (NIDDM), highlighting the importance of early intervention.

Engaging in moderately vigorous aerobic exercise, such as walking or cycling for at least 30 minutes three times a week, is recommended as an effective strategy for preventing NIDDM in individuals with IGT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Management of impaired glucose tolerance: physical training therapy]. Sato, Y., Sato, J., Tokudome, S.[2011]

References

1. England pubmed.ncbi.nlm.nih.gov

Dose-Response Effects of Exercise on Glucose-Lowering Medications for Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Prevention of exercise-related injuries and adverse events in patients with type 2 diabetes. [2013]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Resources to Guide Exercise Specialists Managing Adults with Diabetes. [2020]

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

Long-Term Physical Activity Levels After the End of a Structured Exercise Intervention in Adults With Type 2 Diabetes and Prediabetes: A Systematic Review. [2021]

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

Exercise as a therapeutic intervention for the prevention and treatment of insulin resistance. [2006]

6. Sweden pubmed.ncbi.nlm.nih.gov

Effects of exercise on glucose tolerance and insulin resistance. Brief review and some preliminary results. [2019]

7. Japan pubmed.ncbi.nlm.nih.gov

[Management of impaired glucose tolerance: physical training therapy]. [2011]