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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Low-intensity training combined with blood flow restriction (LI-BFR)
* Behavioral: High-intensity aerobic exercise (HI)
* Behavioral: Low intensity exercise (LI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-intensity training combined with blood flow restriction group (LI-BFR)<br> | Behavioral: Low-intensity training combined with blood flow restriction (LI-BFR)<br>* 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.<br>|
| Active Comparator: High-intensity aerobic exercise group (HI)<br> | Behavioral: High-intensity aerobic exercise (HI)<br>* 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.<br>|
| Placebo Comparator: Low intensity group (LI)<br> | Behavioral: Low intensity exercise (LI)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glucose at baseline | blood glucose level following overnight (12-h) fasting | At baseline, within 7 days before the intervention (observation) starts | 
| Fasting glucose at follow-up | blood glucose level following overnight (12-h) fasting | At week 13, within 7 days after the completion of the 12-week intervention (observation) | 
| Hemoglobin A1c (HbA1c) at baseline | HbA1c level in blood | At baseline, within 7 days before the intervention (observation) starts | 
| Hemoglobin A1c (HbA1c) at follow-up | HbA1c level in blood | At week 13, within 7 days after the completion of the 12-week intervention (observation) | 
| Fasting insulin at baseline | blood insulin level following overnight (12-h) fasting | At baseline, within 7 days before the intervention (observation) starts | 
| Fasting insulin at follow-up | blood insulin level following overnight (12-h) fasting | At week 13, within 7 days after the completion of the 12-week intervention (observation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous glucose monitoring | 14-day continuous glucose monitoring with portable device | At baseline, within 14 days before the intervention (observation) starts, measurement lasts for 14 days | 
| Total sleep duration and total awakening duration at baseline | total sleep duration (in minutes) and total awakening duration after sleep onset (in minutes) assessed by wrist actigraphy (GT3x, Actigraph LLC, Pensacola, FL, USA) | At baseline, within 14 days before the intervention (observation) starts, measurement lasts for at least 7 days | 
| Total sleep duration and total awakening duration at follow-up | total sleep duration (in minutes) and total awakening duration after sleep onset (in minutes) assessed by wrist actigraphy (GT3x, Actigraph LLC, Pensacola, FL, USA) | At week 13, within 14 days after the completion of the 12-week intervention (observation), measurement lasts for at least 7 days | 
| Pittsburg sleep quality index (PSQI) at baseline | Pittsburg sleep quality index global (0-21) and sub-scores (0-3), higher score means poorer quality | At baseline, within 7 days before the intervention (observation) starts | 
| Pittsburg sleep quality index (PSQI) at follow-up | Pittsburg sleep quality index global (0-21) and sub-scores (0-3), higher score means poorer quality | At week 13, within 7 days after the completion of the 12-week intervention (observation) | 
| Height at baseline | height in meters | At baseline, within 7 days before the intervention (observation) starts | 
| Height at follow-up | height in meters | At week 13, within 7 days after the completion of the 12-week intervention (observation) | 
| Weight at baseline | weight in kilograms | At baseline, within 7 days before the intervention (observation) starts | 
| Weight at follow-up | weight in kilograms | At week 13, within 7 days after the completion of the 12-week intervention (observation) | 
| total cholesterol at baseline | total cholesterol level in blood following overnight (12-h) fasting | At baseline, within 7 days before the intervention (observation) starts | 
| total cholesterol at follow-up | total cholesterol level in blood following overnight (12-h) fasting | At week 13, within 7 days after the completion of the 12-week intervention (observation) | 
| triglyceride at baseline | triglyceride level in blood following overnight (12-h) fasting | At baseline, within 7 days before the intervention (observation) starts | 
| triglyceride at follow-up | triglyceride level in blood following overnight (12-h) fasting | At week 13, within 7 days after the completion of the 12-week intervention (observation) | 
| non-esterified fatty acid (NEFA) at baseline | morning NEFA level in blood following overnight (12-h) fasting | At baseline, within 7 days before the intervention (observation) starts | 
| non-esterified fatty acid (NEFA) at follow-up | morning NEFA level in blood following overnight (12-h) fasting | At week 13, within 7 days after the completion of the 12-week intervention (observation) | 
| IL-6 at baseline | morning interleukin-6 level in blood following overnight (12-h) fasting | At baseline, within 7 days before the intervention (observation) starts | 
| IL-6 at follow-up | morning interleukin-6 level in blood following overnight (12-h) fasting | At week 13, within 7 days after the completion of the 12-week intervention (observation) | 
| International Physical Activity Questionnaire - Short Form at baseline | 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. | At baseline, within 7 days before the intervention (observation) starts | 
| International Physical Activity Questionnaire - Short Form at baseline | 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. | At week 13, within 7 days after the completion of the 12-week intervention (observation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood flow restriction training, type 2 diabetes, aerobic exercise, randomized-controlled trial