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Completed

NCT Number: NCT04946799

The Effect of Blood Flow Restriction Training on Glycemic Control Among Type 2 Diabetes Patients

Blood flow restriction training (BFRT) combined with resistance or aerobic exercise has been shown to improve the glucose uptake in humans. In addition, BFRT represents a low-load, alternative exercise program for type 2 diabetes patients who often have reduced physical fitness. However, it is not clear to what extent could BFRT improve glycemic control among patients with type 2 diabetes. This pilot randomized-controlled trial aims to investigate the effect of a 12-week, low-intensity BFRT on glycemic control among patients with type 2 diabetes, compared to medium-high intensity aerobic exercise or low-intensity exercise without BFRT.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing Maigaoqiao Community Healthcare Center

Nanjing, Jiangsu, 210000, China

About this study

Objectives:

The pilot randomized study aims to explore the effects of blood flow restriction combined with aerobic training (BFRT) on the glucose and lipid metabolism indexes and vascular endothelial factors of type 2 diabetes, by comparing it with traditional low-intensity and high-intensity aerobic training. It aims to evaluate the effectiveness of BFRT in glycemic control of type 2 diabetes patients.

Study Population:

A total of 60 patients with type 2 diabetes who are 50-65 years old at the Maigaoqiao Community Health Service Center, Qixia District, Nanjing, China, with a course of type 2 diabetes of 2-10 years will be included as the participants.

Randomization:

Participants will be stratified by baseline hemoglobin A1c (HbA1c) and age, they will be randomly assigned into three groups with a block size of six. The study groups are: 1) low-intensity training combined with blood flow restriction group (LI-BFR group, 40% heart rate reserve combined with 50% arterial occlusion pressure, n=20) 2)high-intensity aerobic exercise group (HI group, 70% heart rate reserve, n=20) 3) Low-intensity group (LI group, 40% heart rate reserve, n=20).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • type 2 diabetes patients diagnosed by at least one of these criteria: 1) random blood glucose >= 11.1mmol/L; 2) fasting blood glucose >= 7.0 mmol/L; 3) 2-hr post oral glucose tolerance test blood glucose >= 11.1mmol/L; 4) hemoglobin A1c >= 6.5%.
  • aged between 50-65 years at baseline
  • disease course of type 2 diabetes between at least 1 year

Exclusion criteria

  • type 1 diabetes
  • fasting blood glucose > 16.7 mmol/L, or suffers frequent hypoglycemia, or have significant glucose fluctuations considered by the physician
  • body mass index > 33 kg/m2
  • severe diabetes complications, including cardiovascular diseases, cerebrovascular diseases, diabetic retinopathy, kidney diseases, diabetic ketoacidosis, and diabetic foot ulcers
  • neuromuscular disorders, sarcopenia, severe osteoporosis, dementia
  • have regular moderate-intensive exercise habit
  • resting systolic blood pressure >= 160 mmHg or resting diastolic blood pressure >= 100 mmHg
  • abnormal electrocardiogram
  • other comorbidities or medications irrelevant to diabetes treatment that may influence glycemia during the past 6 months

Treatment and study plan

Low-intensity training combined with blood flow restriction (LI-BFR)

Behavioral

Participants (n=20) receives low intensity exercise intervention on a cycle ergometer (at 40% of heart rate reserve), with compression belts attached on both thighs, during exercise the belts are inflated with 50% of the participant's arterial occlusion pressure. Exercise is conducted during daytime, 3 times per week, for 12 weeks at Nanjing Maigaoqiao Community Health Service Center. Each exercise session contains 6 sections, each section lasts for 5 minutes, followed with a 1-minute rest period. The compression belt is deflated during the rest period. At least two trained research assistants supervise the exercise in each session. Instant heart rate during exercise is measured with heart rate monitor for each participant.

High-intensity aerobic exercise (HI)

Behavioral

Participants (n=20) receives high intensity aerobic exercise intervention on a cycle ergometer (at 70% of heart rate reserve). Exercise is conducted during daytime, 3 times per week, for 12 weeks at Nanjing Maigaoqiao Community Health Service Center. Each exercise session contains 6 sections, each section lasts for 5 minutes, followed with a 1-minute rest period. At least two trained research assistants supervise the exercise in each session. Instant heart rate during exercise is measured with heart rate monitor for each participant.

Low intensity exercise (LI)

Behavioral

Participants (n=20) receives low intensity exercise intervention on a cycle ergometer (at 40% of heart rate reserve). Exercise is conducted during daytime, 3 times per week, for 12 weeks at Nanjing Maigaoqiao Community Health Service Center. Each exercise session contains 6 sections, each section lasts for 5 minutes, followed with a 1-minute rest period. At least two trained research assistants supervise the exercise in each session. Instant heart rate during exercise is measured with heart rate monitor for each participant.

Primary outcomes

  1. Fasting glucose at baseline

    Time frame: At baseline, within 7 days before the intervention (observation) starts

    blood glucose level following overnight (12-h) fasting

  2. Fasting glucose at follow-up

    Time frame: At week 13, within 7 days after the completion of the 12-week intervention (observation)

    blood glucose level following overnight (12-h) fasting

  3. Hemoglobin A1c (HbA1c) at baseline

    Time frame: At baseline, within 7 days before the intervention (observation) starts

    HbA1c level in blood

  4. Hemoglobin A1c (HbA1c) at follow-up

    Time frame: At week 13, within 7 days after the completion of the 12-week intervention (observation)

    HbA1c level in blood

  5. Fasting insulin at baseline

    Time frame: At baseline, within 7 days before the intervention (observation) starts

    blood insulin level following overnight (12-h) fasting

  6. Fasting insulin at follow-up

    Time frame: At week 13, within 7 days after the completion of the 12-week intervention (observation)

    blood insulin level following overnight (12-h) fasting

Secondary outcomes

  1. Continuous glucose monitoring

    Time frame: At baseline, within 14 days before the intervention (observation) starts, measurement lasts for 14 days

    14-day continuous glucose monitoring with portable device

  2. Total sleep duration and total awakening duration at baseline

    Time frame: At baseline, within 14 days before the intervention (observation) starts, measurement lasts for at least 7 days

    total sleep duration (in minutes) and total awakening duration after sleep onset (in minutes) assessed by wrist actigraphy (GT3x, Actigraph LLC, Pensacola, FL, USA)

  3. Total sleep duration and total awakening duration at follow-up

    Time frame: At week 13, within 14 days after the completion of the 12-week intervention (observation), measurement lasts for at least 7 days

    total sleep duration (in minutes) and total awakening duration after sleep onset (in minutes) assessed by wrist actigraphy (GT3x, Actigraph LLC, Pensacola, FL, USA)

  4. Pittsburg sleep quality index (PSQI) at baseline

    Time frame: At baseline, within 7 days before the intervention (observation) starts

    Pittsburg sleep quality index global (0-21) and sub-scores (0-3), higher score means poorer quality

  5. Pittsburg sleep quality index (PSQI) at follow-up

    Time frame: At week 13, within 7 days after the completion of the 12-week intervention (observation)

    Pittsburg sleep quality index global (0-21) and sub-scores (0-3), higher score means poorer quality

  6. Height at baseline

    Time frame: At baseline, within 7 days before the intervention (observation) starts

    height in meters

  7. Height at follow-up

    Time frame: At week 13, within 7 days after the completion of the 12-week intervention (observation)

    height in meters

  8. Weight at baseline

    Time frame: At baseline, within 7 days before the intervention (observation) starts

    weight in kilograms

  9. Weight at follow-up

    Time frame: At week 13, within 7 days after the completion of the 12-week intervention (observation)

    weight in kilograms

  10. total cholesterol at baseline

    Time frame: At baseline, within 7 days before the intervention (observation) starts

    total cholesterol level in blood following overnight (12-h) fasting

  11. total cholesterol at follow-up

    Time frame: At week 13, within 7 days after the completion of the 12-week intervention (observation)

    total cholesterol level in blood following overnight (12-h) fasting

  12. triglyceride at baseline

    Time frame: At baseline, within 7 days before the intervention (observation) starts

    triglyceride level in blood following overnight (12-h) fasting

  13. triglyceride at follow-up

    Time frame: At week 13, within 7 days after the completion of the 12-week intervention (observation)

    triglyceride level in blood following overnight (12-h) fasting

  14. non-esterified fatty acid (NEFA) at baseline

    Time frame: At baseline, within 7 days before the intervention (observation) starts

    morning NEFA level in blood following overnight (12-h) fasting

  15. non-esterified fatty acid (NEFA) at follow-up

    Time frame: At week 13, within 7 days after the completion of the 12-week intervention (observation)

    morning NEFA level in blood following overnight (12-h) fasting

  16. IL-6 at baseline

    Time frame: At baseline, within 7 days before the intervention (observation) starts

    morning interleukin-6 level in blood following overnight (12-h) fasting

  17. IL-6 at follow-up

    Time frame: At week 13, within 7 days after the completion of the 12-week intervention (observation)

    morning interleukin-6 level in blood following overnight (12-h) fasting

  18. International Physical Activity Questionnaire - Short Form at baseline

    Time frame: At baseline, within 7 days before the intervention (observation) starts

    International Physical Activity Questionnaire (IPAQ) - Short Form for assessing level of physical activity. Level of physical activity are calculated into metabolic equivalent minutes per week (MET mins/wk) according to the answers of the questionnaire. Higher MET mins/wk refers to higher level of physical activity.

  19. International Physical Activity Questionnaire - Short Form at baseline

    Time frame: At week 13, within 7 days after the completion of the 12-week intervention (observation)

    International Physical Activity Questionnaire (IPAQ) - Short Form for assessing level of physical activity. Level of physical activity are calculated into metabolic equivalent minutes per week (MET mins/wk) according to the answers of the questionnaire. Higher MET mins/wk refers to higher level of physical activity.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Nanjing Maigaoqiao Community Health Service Center
  • Nanjing Sport Institute

Registry information

Official study title

Application of Blood Flow Restriction Training in the Exercise Intervention of Chronic Diseases

Acronym: BLFT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 1, 2021
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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