Exercise Interventions for Prediabetes Fatigue

Recruiting at 1 trial location

Overseen By Sandra Hunter, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Insulin, Hormone replacement

Disqualifiers: Neuropathy, Severe obesity, Smoking, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how exercise affects individuals with pre-diabetes, focusing on why leg muscles tire more easily. Researchers aim to determine if blood flow issues in the legs contribute to this fatigue. Participants will engage in either regular leg exercises or exercises with blood flow restriction (Blood Flow Restriction Exercise) to identify which method is more beneficial. This trial may suit adults with pre-diabetes who experience tiredness during exercise. As an unphased trial, it offers a unique opportunity to contribute to understanding the benefits of exercise for pre-diabetes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on insulin, hormone replacement drugs, or vasoactive medications.

What prior data suggests that this exercise intervention is safe for people with prediabetes?

Research has shown that blood flow restriction (BFR) exercise is generally safe and well-tolerated by various groups, including older adults and those recovering from injuries. Studies have found that BFR training can increase muscle strength and size without causing major side effects.

One study found that participants who exercised with blood flow restriction did not experience more negative effects than those who exercised without it, suggesting BFR is safe for most individuals. Another study found that BFR exercise can also improve blood sugar levels and metabolism, which could benefit people with pre-diabetes.

Overall, while BFR exercise is a new approach, current research supports its safety and benefits. However, consulting a healthcare provider before starting any new exercise program is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the exercise interventions for prediabetes fatigue because they explore innovative techniques that could offer new solutions for managing this condition. Unlike standard treatments that may focus on medication or lifestyle changes, these interventions involve low-load knee extension resistance training, with one approach incorporating blood flow restriction (BFR). This BFR technique uses an inflatable cuff to restrict blood flow, potentially enhancing muscle strength and endurance with lighter weights, which might be less taxing on the body. By investigating these methods, researchers hope to find more effective ways to combat fatigue in people with prediabetes, offering an alternative to traditional exercise routines.

What evidence suggests that this trial's exercise interventions could be effective for prediabetes fatigue?

Research has shown that blood flow restriction (BFR) exercise, one of the interventions in this trial, can enhance muscle strength and improve blood vessel function. Studies suggest that BFR exercise may also help the body manage sugar levels better, which is important for people with pre-diabetes. Specifically, one study found that combining BFR with strength training improved blood sugar levels in overweight adults. BFR exercise can also lower blood pressure during workouts, benefiting heart health. These findings suggest that BFR exercise might help reduce tiredness and improve exercise performance in people with pre-diabetes. Participants in this trial will be assigned to either the BFR exercise arm or the Control Exercise arm, which involves low-load knee extension resistance training without blood flow restriction. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 30-85 with pre-diabetes or type 2 diabetes, characterized by specific HbA1c and blood glucose levels. It's not open to smokers, those with poor glycemic control, severe obesity, untreated hypothyroidism, certain medication users, or individuals with cardiovascular or musculoskeletal conditions that limit exercise.

Inclusion Criteria

My HbA1c level is between 6.5% and 10%, indicating I have Type 2 Diabetes.

My blood sugar and HbA1c levels are within the normal range.

I have pre-diabetes with specific blood sugar levels.

Exclusion Criteria

You are a smoker.

Your blood sugar is not well controlled, with a HbA1c level above 10%.

I am taking medication for advanced type 2 diabetes, including insulin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform 8 weeks of dynamic unilateral resistance exercise training with and without blood flow restriction

8 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in strength, blood flow, muscle oxygenation, and other physiological measures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Blood Flow Restriction Exercise
• Control Exercise

Trial Overview

The study investigates why people with pre-diabetes experience increased muscle fatigue during exercise. Participants will undergo a novel exercise regimen that includes restricting blood flow to the limbs to understand vascular contributions to this fatigability.

How Is the Trial Designed?

Group I: Control Exercise Experimental Treatment 1 Intervention

Low-load knee extension resistance training (20% of 1-RM) without blood flow restriction. A 10-cm wide inflatable cuff will be placed around the upper portion of the thigh but not inflated.

Group II: Blood Flow Restriction Exercise Experimental Treatment 1 Intervention

Low-load knee extension resistance training (20% of 1-RM) with blood flow restriction using a 10-cm wide inflatable cuff placed around the most proximal part of the exercising thigh. Blood flow will be restricted in the BFR leg at above the limb occlusion pressure of the and this will be determined prior to the exercise while the participant is seated in the knee extensor machine. The cuff pressure during the BFR protocol will be 10 mmHg above limb occlusion pressure.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

University of Wisconsin, Madison

Collaborator

Trials

1,249

Recruited

3,255,000+

Marquette University

Collaborator

Trials

68

Recruited

202,000+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

Medical College of Wisconsin

Collaborator

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

Prediabetes includes different phenotypes—impaired fasting glucose (IFG), impaired glucose tolerance (IGT), and a combination of both—each associated with varying risks for developing type 2 diabetes and cardiovascular disease.

Understanding the distinct metabolic mechanisms behind these phenotypes can help tailor exercise interventions, as some individuals may not respond well to traditional exercise due to their specific prediabetes characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise resistance across the prediabetes phenotypes: Impact on insulin sensitivity and substrate metabolism. Malin, SK., Liu, Z., Barrett, EJ., et al.[2018]

Blood flow restriction training (BFRT) is generally safe for patients with musculoskeletal disorders, with a systematic review of 19 studies involving 322 participants showing that most did not report adverse events.

While some rare adverse events were noted, such as deep vein thrombosis and rhabdomyolysis, individuals undergoing BFRT did not experience more adverse events compared to those doing regular exercise, indicating its potential as a safe strengthening method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Blood Flow Restriction Training as a Therapeutic Intervention for Patients With Musculoskeletal Disorders: A Systematic Review. Minniti, MC., Statkevich, AP., Kelly, RL., et al.[2020]

High-intensity interval training (HIIT) significantly improves endothelial function and blood pressure in patients with type 2 diabetes by increasing levels of adropin and nitrite/nitrate (NOx), compared to moderate-intensity continuous training (MICT).

In a study of 66 participants over 12 weeks, both HIIT and MICT increased flow-mediated dilatation (FMD) and peak oxygen consumption, but HIIT resulted in greater increases in adropin and NOx, which are linked to better vascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved blood pressure and flow-mediated dilatation via increased plasma adropin and nitrate/nitrite induced by high-intensity interval training in patients with type 2 diabetes. Davoodi, M., Hesamabadi, BK., Ariabood, E., et al.[2022]

A 24-month study involving 137 participants with prediabetes showed that aerobic training (AT), resistance training (RT), and combined training (AT + RT) significantly reduced the incidence of type 2 diabetes (T2D) by 74%, 65%, and 72% respectively, compared to a control group.

All exercise groups also demonstrated improved blood glucose and lipid profiles, indicating that both RT and combined training are effective alternatives to aerobic training alone in preventing T2D progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year-supervised resistance training prevented diabetes incidence in people with prediabetes: A randomised control trial. Dai, X., Zhai, L., Chen, Q., et al.[2020]

Blood flow restriction (BFR) training is gaining popularity for its ability to enhance muscle mass, strength, and cardiovascular function, making it a valuable tool in fitness and rehabilitation.

Despite its benefits, practitioners face challenges in implementing BFR training, such as determining appropriate pressure levels, ensuring access to technology, conducting thorough medical screenings, and managing the perceived discomfort of the training to encourage long-term adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived Barriers to Blood Flow Restriction Training. Rolnick, N., Kimbrell, K., Cerqueira, MS., et al.[2022]

Blood flow-restricted resistance training (BFR-RT) is safe and effective for improving systolic blood pressure in patients with coronary artery disease (CAD), showing a significant reduction of 10 mm Hg after 8 weeks of training.

BFR-RT combined with aerobic training did not negatively affect hemostatic markers, indicating it can be a beneficial addition to cardiac rehabilitation programs without adverse effects on blood clotting factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamic and Hemostatic Response to Blood Flow Restriction Resistance Exercise in Coronary Artery Disease: A Pilot Randomized Controlled Trial. Kambič, T., Novaković, M., Tomažin, K., et al.[2021]

A systematic review of 47 studies involving over 8000 individuals with prediabetes or diabetes found that while there are some risks associated with increased physical activity, such as musculoskeletal injuries and hypoglycemia, the overall prevalence of severe adverse events is low.

The review supports that increased physical activity is generally safe for individuals with prediabetes and diabetes, and it led to the development of a new risk assessment algorithm to help guide safe exercise practices for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based risk assessment and recommendations for physical activity clearance: diabetes mellitus and related comorbidities. Riddell, MC., Burr, J.[2022]

Resistance training (RT) is as effective as aerobic training (AT) in improving metabolic control and preserving β-cell function in individuals with prediabetes, based on a study of 248 Chinese participants over 6 months.

Both RT and AT significantly reduced HbA1c levels compared to a control group, indicating that both forms of exercise can help manage blood sugar levels in people at risk for type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the effects of 6 months aerobic exercise and resistance training on metabolic control and β-cell function in Chinese patients with prediabetes: A multicenter randomized controlled trial. Yuan, X., Dai, X., Liu, L., et al.[2022]

Blood flow restriction training (BFRT) can be beneficial for rehabilitation but poses risks such as increased blood pressure and adverse cardiovascular responses, especially in individuals with pre-existing conditions like hypertension and diabetes.

To ensure safety, a risk stratification tool is recommended for clinicians to assess patients' medical histories and identify those who may be at higher risk for complications when undergoing BFRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Useful Blood Flow Restriction Training Risk Stratification for Exercise and Rehabilitation. Nascimento, DDC., Rolnick, N., Neto, IVS., et al.[2022]

In a study involving 20 healthy participants, alternating (ALT) blood flow restriction (BFR) exercise resulted in significantly higher cardiovascular responses, including greater increases in aortic and mean arterial blood pressures compared to unilateral (UNI) and bilateral (BIL) patterns.

For individuals concerned about cardiovascular strain, unilateral or bilateral BFR exercises may be safer options than alternating patterns, as they produced lower cardiovascular responses during the exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute cardiovascular response to unilateral, bilateral, and alternating resistance exercise with blood flow restriction. Stanford, DM., Park, J., Jones, R., et al.[2021]

Lifestyle interventions, particularly increased physical activity, can prevent the progression from pre-diabetes to Type 2 diabetes and improve cardiovascular risk factors, as shown in various studies reviewed.

One recent trial indicated that such interventions may directly reduce cardiovascular events, including mortality, strokes, and heart attacks, highlighting the potential of physical activity in managing health risks for pre-diabetic individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Change in daily ambulatory activity and cardiovascular events in people with impaired glucose tolerance. Popp Switzer, M., Elhanafi, S., San Juan, ZT.[2018]

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]

In a study of 22 obese individuals with prediabetes, high-intensity interval training (INT) was found to significantly improve fat oxidation during exercise compared to continuous training (CONT), indicating a more effective approach for this population.

Participants who engaged in INT not only lost more body mass and increased their peak oxygen consumption (VO2peak) but also showed greater fat oxidation during exercise at the same relative intensity, suggesting that INT may be a superior training method for enhancing metabolic health in prediabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two Weeks of Interval Training Enhances Fat Oxidation during Exercise in Obese Adults with Prediabetes. Gaitán, JM., Eichner, NZM., Gilbertson, NM., et al.[2020]

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