BFR Walking for Insulin and Aerobic Improvement in Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

— BRAID  

Official title:

Evaluating the Impact of Blood-Flow Restriction Walk Training on Insulin Sensitivity and Aerobic Capacity in Individuals With Type 2 Diabetes Mellitus: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06290947
• Other study ID #: BFR-AE-DT2-2023-01
• Secondary ID: IRB 2022/C/20/N
• Status: Completed
• Phase: N/A
• Start date: March 6, 2022
• Est. completion date: January 8, 2024

Study information

• Verified date: March 2024
• Source: Arab American University (Palestine)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial examines the impact of Blood-Flow Restriction Walk Training (BFRw) on insulin sensitivity and aerobic capacity in individuals with Type 2 Diabetes (T2D).

The primary objectives of the study are to determine: If Blood-Flow Restriction Walk Training (BFRw) can improve insulin sensitivity in individuals with Type 2 Diabetes (T2D).

Whether Blood-Flow Restriction Walk Training (BFRw) enhances aerobic capacity in individuals with Type 2 Diabetes (T2D).

Participants in the study are divided into two groups. One group undergoes Blood-Flow Restriction Walk Training (BFRw), and the other serves as a control. Both groups attend three treadmill walking sessions weekly for eight weeks. The BFRw group has a restriction cuff placed around both thighs during their sessions, while the control group participates in the walking sessions without any blood flow restriction.

Hemoglobin A1c (HbA1c) levels and maximal oxygen consumption (VO2 max) are monitored as indicators of insulin sensitivity and aerobic capacity, respectively.

Description:

In this clinical trial, the efficacy of Blood-Flow Restriction Walk Training (BFRw) as a therapeutic modality to enhance insulin sensitivity and aerobic capacity is meticulously explored among individuals diagnosed with Type 2 Diabetes. This innovative approach combines the simplicity of low-intensity walking exercises with the physiological benefits of blood-flow restriction applied to the lower extremities, proposing that such a combination can induce muscle adaptations typically associated with high-intensity resistance training.

The study is centered around a rigorously structured protocol, in which participants assigned to the intervention arm undergo supervised BFRw sessions. These sessions are carefully calibrated to ensure a balance between safety and effectiveness, with a focus on gradually increasing the intensity and duration of the exercise to accommodate the varying fitness levels of participants and to mitigate any potential risks associated with blood-flow restriction techniques.

The research primarily investigates the hypothesis that BFRw can lead to significant improvements in metabolic health markers and physical performance metrics without the physical strain associated with traditional high-intensity exercise regimes. By examining the incremental adaptation of skeletal muscle under conditions of reduced oxygen supply, the study aims to uncover the mechanisms through which BFRw supports enhancements in glucose metabolism and cardiovascular fitness.

Furthermore, the study seeks to identify the optimal parameters for blood-flow restriction that maximize therapeutic benefits while minimizing discomfort and potential complications. This involves comprehensive assessments of insulin sensitivity (via glucose tolerance tests and insulin assays) and aerobic capacity (measured through graded exercise testing to determine VO2 max).

This investigation is designed to provide valuable insights into the feasibility, safety, and efficacy of incorporating Blood-Flow Restriction Walk Training into the treatment regimen for Type 2 Diabetes. By redefining exercise recommendations for individuals with limited tolerance for traditional high-intensity workouts, the research could significantly impact future guidelines and practices for managing this prevalent metabolic disorder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 8, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male individuals of Palestinian descent

• Aged between 40 to 65 years

• Diagnosed with Type 2 Diabetes for a duration of 2 to 10 years, with ongoing medical supervision

• Capable of understanding and following the study's instructions, programs, and protocols

Exclusion Criteria:

• Females, due to hormonal and metabolic differences.

• Individuals outside the 40-65 age range to minimize age-related variations in Diabetes Mellitus.

• Patients with conditions or comorbidities that impair walking or elevate the risk associated with Blood-Flow Restriction Training (BFRT).

• An Ankle Brachial Pressure Index (ABI) greater than 0.9, as values outside the normal range (0.9 to 1.4) may indicate Peripheral Arterial Disease (PAD) or Cardiovascular Disease (CVD), affecting eligibility for participation.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Device:
• BFR Cuffs for Intervention Group
The intervention consists of supervised treadmill sessions incorporating specialized BFR cuffs, branded as "H+ Curve," tailored for Blood-Flow Restriction Walk Training (BFRw). These cuffs are strategically positioned on the upper portion of the lower limbs to induce muscle adaptations and improve metabolic health outcomes. The innovative protocol is designed to probe the potential benefits of BFRw in ameliorating insulin sensitivity and enhancing aerobic capacity, thus presenting a pioneering exercise approach for individuals with Type 2 Diabetes.

Other:
• Standard Walking Training Program
The control group will engage in a standard walking training regimen, consisting of supervised treadmill sessions without the application of BFR cuffs. This protocol serves to uphold the scientific rigor of the study by offering a comparison group for the BFRw intervention. Purpose: To evaluate the impact of a typical exercise routine on insulin sensitivity and aerobic capacity, thereby establishing a control benchmark to contrast with the effects of the BFRw intervention.

Locations

Country	Name	City	State
Palestinian Territory, occupied	Arab American University - Palestine	Jenin

Sponsors (1)

Lead Sponsor	Collaborator
Arab American University (Palestine)

Country where clinical trial is conducted

Palestinian Territory, occupied, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Insulin Sensitivity	This measure assesses the change in insulin sensitivity determined by cumulative sugar measure.	8 weeks
Primary	Improvement in Aerobic Capacity	This outcome measure will evaluate the change in aerobic capacity as indicated by VO2 max (maximal oxygen consumption) levels. This assessment will determine the effectiveness of Blood-Flow Restriction Walk Training in enhancing aerobic efficiency in participants.	8 weeks
Secondary	Change in Body Mass Index (BMI)	This outcome will track the change in participants' Body Mass Index (BMI) to assess any impact of Blood-Flow Restriction Walk Training on body composition. BMI will be calculated using measured weight and height at baseline and at the end of the study period.	8 weeks