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

Type 2 Diabetes Clinical Trial

— BLFT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04946799
• Other study ID #: HK-LLWYH-202002
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: January 30, 2022

Study information

• Verified date: May 2022
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 30, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Low-intensity training combined with blood flow restriction (LI-BFR)
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)
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)
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.

Locations

Country	Name	City	State
China	Nanjing Maigaoqiao Community Healthcare Center	Nanjing	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Uppsala University	Nanjing Maigaoqiao Community Health Service Center, Nanjing Sport Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting glucose at baseline	blood glucose level following overnight (12-h) fasting	At baseline, within 7 days before the intervention (observation) starts
Primary	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)
Primary	Hemoglobin A1c (HbA1c) at baseline	HbA1c level in blood	At baseline, within 7 days before the intervention (observation) starts
Primary	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)
Primary	Fasting insulin at baseline	blood insulin level following overnight (12-h) fasting	At baseline, within 7 days before the intervention (observation) starts
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	Height at baseline	height in meters	At baseline, within 7 days before the intervention (observation) starts
Secondary	Height at follow-up	height in meters	At week 13, within 7 days after the completion of the 12-week intervention (observation)
Secondary	Weight at baseline	weight in kilograms	At baseline, within 7 days before the intervention (observation) starts
Secondary	Weight at follow-up	weight in kilograms	At week 13, within 7 days after the completion of the 12-week intervention (observation)
Secondary	total cholesterol at baseline	total cholesterol level in blood following overnight (12-h) fasting	At baseline, within 7 days before the intervention (observation) starts
Secondary	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)
Secondary	triglyceride at baseline	triglyceride level in blood following overnight (12-h) fasting	At baseline, within 7 days before the intervention (observation) starts
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)