Clinical trial NCT04946799: The Effect of Blood Flow Restriction Training on Glycemic Control Among Type 2 Diabetes Patients
Official title: Application of Blood Flow Restriction Training in the Exercise Intervention of Chronic Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: blood flow restriction training
type 2 diabetes
aerobic exercise
randomized-controlled trial
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Nanjing Sport Institute
name: Nanjing Maigaoqiao Community Health Service Center
First posted: 2021-07-01
Enrollment: 54
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Fasting glucose at baseline
timeFrame: At baseline, within 7 days before the intervention (observation) starts
measure: Fasting glucose at follow-up
timeFrame: At week 13, within 7 days after the completion of the 12-week intervention (observation)
measure: Hemoglobin A1c (HbA1c) at baseline
timeFrame: At baseline, within 7 days before the intervention (observation) starts
measure: Hemoglobin A1c (HbA1c) at follow-up
timeFrame: At week 13, within 7 days after the completion of the 12-week intervention (observation)
measure: Fasting insulin at baseline
timeFrame: At baseline, within 7 days before the intervention (observation) starts
measure: Fasting insulin at follow-up
timeFrame: At week 13, within 7 days after the completion of the 12-week intervention (observation)
Secondary outcomes:
measure: Continuous glucose monitoring
timeFrame: At baseline, within 14 days before the intervention (observation) starts, measurement lasts for 14 days
measure: Total sleep duration and total awakening duration at baseline
timeFrame: At baseline, within 14 days before the intervention (observation) starts, measurement lasts for at least 7 days
measure: Total sleep duration and total awakening duration at follow-up
timeFrame: At week 13, within 14 days after the completion of the 12-week intervention (observation), measurement lasts for at least 7 days
measure: Pittsburg sleep quality index (PSQI) at baseline
timeFrame: At baseline, within 7 days before the intervention (observation) starts
measure: Pittsburg sleep quality index (PSQI) at follow-up
timeFrame: At week 13, within 7 days after the completion of the 12-week intervention (observation)
measure: Height at baseline
timeFrame: At baseline, within 7 days before the intervention (observation) starts
measure: Height at follow-up
timeFrame: At week 13, within 7 days after the completion of the 12-week intervention (observation)
measure: Weight at baseline
timeFrame: At baseline, within 7 days before the intervention (observation) starts
measure: Weight at follow-up
timeFrame: At week 13, within 7 days after the completion of the 12-week intervention (observation)
measure: total cholesterol at baseline
timeFrame: At baseline, within 7 days before the intervention (observation) starts
measure: total cholesterol at follow-up
timeFrame: At week 13, within 7 days after the completion of the 12-week intervention (observation)
measure: triglyceride at baseline
timeFrame: At baseline, within 7 days before the intervention (observation) starts
measure: triglyceride at follow-up
timeFrame: At week 13, within 7 days after the completion of the 12-week intervention (observation)
measure: non-esterified fatty acid (NEFA) at baseline
timeFrame: At baseline, within 7 days before the intervention (observation) starts
measure: non-esterified fatty acid (NEFA) at follow-up
timeFrame: At week 13, within 7 days after the completion of the 12-week intervention (observation)
measure: IL-6 at baseline
timeFrame: At baseline, within 7 days before the intervention (observation) starts
measure: IL-6 at follow-up
timeFrame: At week 13, within 7 days after the completion of the 12-week intervention (observation)
measure: International Physical Activity Questionnaire - Short Form at baseline
timeFrame: At baseline, within 7 days before the intervention (observation) starts
measure: International Physical Activity Questionnaire - Short Form at baseline
timeFrame: At week 13, within 7 days after the completion of the 12-week intervention (observation)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maigaoqiao Community Healthcare Center
state: Jiangsu
Study officials:
affiliation: Nanjing Sport Institute
name: Yan Zhao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University
name: Xiao Tan, PhD
role: STUDY_DIRECTOR
References: