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Exercise Interventions for Prediabetes Fatigue

N/A

Recruiting

Research Sponsored by Marquette University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Type 2 Diabetes Mellitus with elevated glycosylated hemoglobin (HbA1c) >6.5% and <10%

Controls with normoglycemic status having a HbA1c level ≤5.6% and fasting blood glucose ≤ 99 mg/dL (5.5 mmol/L)

Must not have

Medications associated with advanced stages of T2D including insulin

Cardiovascular or musculoskeletal disease that preclude exercise testing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one session before and then after 8 weeks of training

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers understand why people with pre-diabetes are more fatigued during exercise, in hopes of developing more effective exercise programs.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the document does not specify side effects directly related to the interventions being tested (Control Exercise and Blood Flow Restriction Exercise), potential risks may include discomfort from restricted blood flow or muscle soreness post-exercise.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I have pre-diabetes with specific blood sugar levels.

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I am between 30 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have heart or muscle/bone conditions that prevent me from doing exercise tests.

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I have swelling in my arms or legs.

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I have untreated hypothyroidism.

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I am taking hormone replacement or blood flow affecting drugs.

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I experience symptoms like numbness or tingling.

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My BMI is over 45.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one session before and then after 8 weeks of training

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one session before and then after 8 weeks of training

This trial's timeline: 3 weeks for screening, Varies for treatment, and one session before and then after 8 weeks of training for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Capillary density

Fatigability - Reduction in Power

Leg Blood Flow

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Control ExerciseExperimental Treatment1 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 ExerciseExperimental Treatment1 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.

0 / 11Eligibility criteria met