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

Uppsala University

Status

Completed

Conditions

Type 2 Diabetes

Treatments

Behavioral: High-intensity aerobic exercise (HI)

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

Behavioral: Low intensity exercise (LI)

Study type

Interventional

Funder types

Other

Identifiers

NCT04946799

HK-LLWYH-202002

Details and patient eligibility

About

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.

Full 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).

Enrollment

54 patients

Sex

All

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

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