The Effect of Blood Flow Restriction Training on Glycemic Control Among Type 2 Diabetes Patients
- Conditions
- Type 2 Diabetes
- Interventions
- Behavioral: Low intensity exercise (LI)Behavioral: Low-intensity training combined with blood flow restriction (LI-BFR)Behavioral: High-intensity aerobic exercise (HI)
- Registration Number
- NCT04946799
- Lead Sponsor
- Uppsala University
- Brief Summary
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
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low intensity group (LI) Low intensity exercise (LI) - Low-intensity training combined with blood flow restriction group (LI-BFR) Low-intensity training combined with blood flow restriction (LI-BFR) - High-intensity aerobic exercise group (HI) High-intensity aerobic exercise (HI) -
- Primary Outcome Measures
Name Time Method Hemoglobin A1c (HbA1c) at follow-up At week 13, within 7 days after the completion of the 12-week intervention (observation) HbA1c level in blood
Fasting glucose at baseline At baseline, within 7 days before the intervention (observation) starts blood glucose level following overnight (12-h) fasting
Fasting glucose at follow-up At week 13, within 7 days after the completion of the 12-week intervention (observation) blood glucose level following overnight (12-h) fasting
Fasting insulin at baseline At baseline, within 7 days before the intervention (observation) starts blood insulin level following overnight (12-h) fasting
Hemoglobin A1c (HbA1c) at baseline At baseline, within 7 days before the intervention (observation) starts HbA1c level in blood
Fasting insulin at follow-up At week 13, within 7 days after the completion of the 12-week intervention (observation) blood insulin level following overnight (12-h) fasting
- Secondary Outcome Measures
Name Time Method Continuous glucose monitoring At baseline, within 14 days before the intervention (observation) starts, measurement lasts for 14 days 14-day continuous glucose monitoring with portable device
Weight at follow-up At week 13, within 7 days after the completion of the 12-week intervention (observation) weight in kilograms
non-esterified fatty acid (NEFA) at baseline At baseline, within 7 days before the intervention (observation) starts morning NEFA level in blood following overnight (12-h) fasting
Pittsburg sleep quality index (PSQI) at follow-up 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
Total sleep duration and total awakening duration at baseline 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)
Height at baseline At baseline, within 7 days before the intervention (observation) starts height in meters
Height at follow-up At week 13, within 7 days after the completion of the 12-week intervention (observation) height in meters
Weight at baseline At baseline, within 7 days before the intervention (observation) starts weight in kilograms
Total sleep duration and total awakening duration at follow-up 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)
Pittsburg sleep quality index (PSQI) at baseline 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
total cholesterol at baseline At baseline, within 7 days before the intervention (observation) starts total cholesterol level in blood following overnight (12-h) fasting
total cholesterol at follow-up 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
triglyceride at baseline At baseline, within 7 days before the intervention (observation) starts triglyceride level in blood following overnight (12-h) fasting
triglyceride at follow-up At week 13, within 7 days after the completion of the 12-week intervention (observation) triglyceride level in blood following overnight (12-h) fasting
non-esterified fatty acid (NEFA) at follow-up 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
IL-6 at follow-up 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
International Physical Activity Questionnaire - Short Form at baseline 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.
IL-6 at baseline At baseline, within 7 days before the intervention (observation) starts morning interleukin-6 level in blood following overnight (12-h) fasting
Trial Locations
- Locations (1)
Nanjing Maigaoqiao Community Healthcare Center
🇨🇳Nanjing, Jiangsu, China