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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Low-intensity training combined with blood flow restriction (LI-BFR)
High-intensity aerobic exercise (HI)
Low intensity exercise (LI)
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring blood flow restriction training, type 2 diabetes, aerobic exercise, randomized-controlled trial

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Nanjing Maigaoqiao Community Healthcare Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

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

High-intensity aerobic exercise group (HI)

Low intensity group (LI)

Arm Description

Outcomes

Primary Outcome Measures

Fasting glucose at baseline
blood glucose level following overnight (12-h) fasting
Fasting glucose at follow-up
blood glucose level following overnight (12-h) fasting
Hemoglobin A1c (HbA1c) at baseline
HbA1c level in blood
Hemoglobin A1c (HbA1c) at follow-up
HbA1c level in blood
Fasting insulin at baseline
blood insulin level following overnight (12-h) fasting
Fasting insulin at follow-up
blood insulin level following overnight (12-h) fasting

Secondary Outcome Measures

Continuous glucose monitoring
14-day continuous glucose monitoring with portable device
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)
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)
Pittsburg sleep quality index (PSQI) at baseline
Pittsburg sleep quality index global (0-21) and sub-scores (0-3), higher score means poorer quality
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
Height at baseline
height in meters
Height at follow-up
height in meters
Weight at baseline
weight in kilograms
Weight at follow-up
weight in kilograms
total cholesterol at baseline
total cholesterol level in blood following overnight (12-h) fasting
total cholesterol at follow-up
total cholesterol level in blood following overnight (12-h) fasting
triglyceride at baseline
triglyceride level in blood following overnight (12-h) fasting
triglyceride at follow-up
triglyceride level in blood following overnight (12-h) fasting
non-esterified fatty acid (NEFA) at baseline
morning NEFA level in blood following overnight (12-h) fasting
non-esterified fatty acid (NEFA) at follow-up
morning NEFA level in blood following overnight (12-h) fasting
IL-6 at baseline
morning interleukin-6 level in blood following overnight (12-h) fasting
IL-6 at follow-up
morning interleukin-6 level in blood following overnight (12-h) fasting
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.
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.

Full Information

First Posted
May 31, 2021
Last Updated
May 17, 2022
Sponsor
Uppsala University
Collaborators
Nanjing Sport Institute, Nanjing Maigaoqiao Community Health Service Center
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1. Study Identification

Unique Protocol Identification Number
NCT04946799
Brief Title
The Effect of Blood Flow Restriction Training on Glycemic Control Among Type 2 Diabetes Patients
Acronym
BLFT
Official Title
Application of Blood Flow Restriction Training in the Exercise Intervention of Chronic Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
January 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
Nanjing Sport Institute, Nanjing Maigaoqiao Community Health Service Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
blood flow restriction training, type 2 diabetes, aerobic exercise, randomized-controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-intensity training combined with blood flow restriction group (LI-BFR)
Arm Type
Experimental
Arm Title
High-intensity aerobic exercise group (HI)
Arm Type
Active Comparator
Arm Title
Low intensity group (LI)
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Low-intensity training combined with blood flow restriction (LI-BFR)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
High-intensity aerobic exercise (HI)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low intensity exercise (LI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fasting glucose at baseline
Description
blood glucose level following overnight (12-h) fasting
Time Frame
At baseline, within 7 days before the intervention (observation) starts
Title
Fasting glucose at follow-up
Description
blood glucose level following overnight (12-h) fasting
Time Frame
At week 13, within 7 days after the completion of the 12-week intervention (observation)
Title
Hemoglobin A1c (HbA1c) at baseline
Description
HbA1c level in blood
Time Frame
At baseline, within 7 days before the intervention (observation) starts
Title
Hemoglobin A1c (HbA1c) at follow-up
Description
HbA1c level in blood
Time Frame
At week 13, within 7 days after the completion of the 12-week intervention (observation)
Title
Fasting insulin at baseline
Description
blood insulin level following overnight (12-h) fasting
Time Frame
At baseline, within 7 days before the intervention (observation) starts
Title
Fasting insulin at follow-up
Description
blood insulin level following overnight (12-h) fasting
Time Frame
At week 13, within 7 days after the completion of the 12-week intervention (observation)
Secondary Outcome Measure Information:
Title
Continuous glucose monitoring
Description
14-day continuous glucose monitoring with portable device
Time Frame
At baseline, within 14 days before the intervention (observation) starts, measurement lasts for 14 days
Title
Total sleep duration and total awakening duration at baseline
Description
total sleep duration (in minutes) and total awakening duration after sleep onset (in minutes) assessed by wrist actigraphy (GT3x, Actigraph LLC, Pensacola, FL, USA)
Time Frame
At baseline, within 14 days before the intervention (observation) starts, measurement lasts for at least 7 days
Title
Total sleep duration and total awakening duration at follow-up
Description
total sleep duration (in minutes) and total awakening duration after sleep onset (in minutes) assessed by wrist actigraphy (GT3x, Actigraph LLC, Pensacola, FL, USA)
Time Frame
At week 13, within 14 days after the completion of the 12-week intervention (observation), measurement lasts for at least 7 days
Title
Pittsburg sleep quality index (PSQI) at baseline
Description
Pittsburg sleep quality index global (0-21) and sub-scores (0-3), higher score means poorer quality
Time Frame
At baseline, within 7 days before the intervention (observation) starts
Title
Pittsburg sleep quality index (PSQI) at follow-up
Description
Pittsburg sleep quality index global (0-21) and sub-scores (0-3), higher score means poorer quality
Time Frame
At week 13, within 7 days after the completion of the 12-week intervention (observation)
Title
Height at baseline
Description
height in meters
Time Frame
At baseline, within 7 days before the intervention (observation) starts
Title
Height at follow-up
Description
height in meters
Time Frame
At week 13, within 7 days after the completion of the 12-week intervention (observation)
Title
Weight at baseline
Description
weight in kilograms
Time Frame
At baseline, within 7 days before the intervention (observation) starts
Title
Weight at follow-up
Description
weight in kilograms
Time Frame
At week 13, within 7 days after the completion of the 12-week intervention (observation)
Title
total cholesterol at baseline
Description
total cholesterol level in blood following overnight (12-h) fasting
Time Frame
At baseline, within 7 days before the intervention (observation) starts
Title
total cholesterol at follow-up
Description
total cholesterol level in blood following overnight (12-h) fasting
Time Frame
At week 13, within 7 days after the completion of the 12-week intervention (observation)
Title
triglyceride at baseline
Description
triglyceride level in blood following overnight (12-h) fasting
Time Frame
At baseline, within 7 days before the intervention (observation) starts
Title
triglyceride at follow-up
Description
triglyceride level in blood following overnight (12-h) fasting
Time Frame
At week 13, within 7 days after the completion of the 12-week intervention (observation)
Title
non-esterified fatty acid (NEFA) at baseline
Description
morning NEFA level in blood following overnight (12-h) fasting
Time Frame
At baseline, within 7 days before the intervention (observation) starts
Title
non-esterified fatty acid (NEFA) at follow-up
Description
morning NEFA level in blood following overnight (12-h) fasting
Time Frame
At week 13, within 7 days after the completion of the 12-week intervention (observation)
Title
IL-6 at baseline
Description
morning interleukin-6 level in blood following overnight (12-h) fasting
Time Frame
At baseline, within 7 days before the intervention (observation) starts
Title
IL-6 at follow-up
Description
morning interleukin-6 level in blood following overnight (12-h) fasting
Time Frame
At week 13, within 7 days after the completion of the 12-week intervention (observation)
Title
International Physical Activity Questionnaire - Short Form at baseline
Description
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.
Time Frame
At baseline, within 7 days before the intervention (observation) starts
Title
International Physical Activity Questionnaire - Short Form at baseline
Description
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.
Time Frame
At week 13, within 7 days after the completion of the 12-week intervention (observation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Zhao, MD, PhD
Organizational Affiliation
Nanjing Sport Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiao Tan, PhD
Organizational Affiliation
Uppsala University
Official's Role
Study Director
Facility Information:
Facility Name
Nanjing Maigaoqiao Community Healthcare Center
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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