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Exercise Interventions for Prediabetes Fatigue

N/A
Waitlist Available
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one session before and then after 8 weeks of training
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Capillary density
Fatigability - Reduction in Power
Leg Blood Flow
+5 more

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.

Find a Location

Who is running the clinical trial?

Marquette UniversityLead Sponsor
62 Previous Clinical Trials
200,243 Total Patients Enrolled
University of Illinois at ChicagoOTHER
609 Previous Clinical Trials
1,559,229 Total Patients Enrolled
Medical College of WisconsinOTHER
609 Previous Clinical Trials
1,162,503 Total Patients Enrolled

Media Library

Blood Flow Restriction Exercise Clinical Trial Eligibility Overview. Trial Name: NCT04442451 — N/A
Type 2 Diabetes Research Study Groups: Control Exercise, Blood Flow Restriction Exercise
Type 2 Diabetes Clinical Trial 2023: Blood Flow Restriction Exercise Highlights & Side Effects. Trial Name: NCT04442451 — N/A
Blood Flow Restriction Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT04442451 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age range of participants in this trial restricted to those over 25?

"Eligible candidates for this study must be between 30 and 85 years old. There are 192 trials limited to applicants who have not yet reached the age of majority, while 1116 exist for elderly patients over 65."

Answered by AI

Are participants still able to join this clinical exploration?

"While clinicaltrials.gov records indicate that this trial is not currently recruiting, it was initially posted on October 1st 2024 and last updated on August 22nd 2023. At present time, there are 1460 alternative studies seeking participants."

Answered by AI

Who meets the criteria to partake in this analysis?

"This medical trial requires 80 participants of both genders between the ages 30 and 85 suffering from Type 2 diabetes. To be eligible, candidates must meet a set of criteria including: male or female adults 40 to 75 years old; pre-diabetics with HbA1c levels 5.7 - 6.4% and fasting blood glucose 100 - 125 mg/dL at initial screening; control groups consisting of normoglycemics with HbA1c ≤5.6% and FBG ≤99mg/dL (5.5 mmol/L) as well as diabetics who have elevated glycosylated hem"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Mechanisms of Fatigability With Diabetes
2024. "Mechanisms of Fatigability With Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04442451.
All > Prediabetes
~53 spots leftby Jan 2027
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