Type 2 DiabetesBLFTNCT04946799

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

A study testing Low-intensity training combined with blood flow restriction (LI-BFR), High-intensity aerobic exercise (HI) and Low intensity exercise (LI) in people with Type 2 Diabetes, run by Uppsala University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 45 to 75 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Low-intensity training combined with blood flow restriction (LI-BFR), High-intensity aerobic exercise (HI) and Low intensity exercise (LI)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 54 participants
Where: 1 siteChina
Study dates: 1 Jul 2021to 30 Jan 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

China1 site

Nanjing Maigaoqiao Community Healthcare Center
Nanjing, Jiangsu, 210000

Other trials in China

About this study

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

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.

Read the 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).

Conditions: Type 2 Diabetes
Being tested: Low-intensity training combined with blood flow restriction (LI-BFR), High-intensity aerobic exercise (HI), Low intensity exercise (LI)
Keywords: blood flow restriction training, type 2 diabetes, aerobic exercise, randomized-controlled trial
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04946799
Study group	Role	What they receive
Low-intensity training combined with blood flow restriction group (LI-BFR)	Experimental	Not described Receives: Behavioral: Low-intensity training combined with blood flow restriction (LI-BFR)
High-intensity aerobic exercise group (HI)	Active comparator	Not described Receives: Behavioral: High-intensity aerobic exercise (HI)
Low intensity group (LI)	Placebo comparator	Not described Receives: Behavioral: Low intensity exercise (LI)

What is being measured

The primary outcome is the main question the study is designed to answer.

Fasting glucose at baseline
blood glucose level following overnight (12-h) fasting
Measured: At baseline, within 7 days before the intervention (observation) starts
Fasting glucose at follow-up
blood glucose level following overnight (12-h) fasting
Measured: At week 13, within 7 days after the completion of the 12-week intervention (observation)
Hemoglobin A1c (HbA1c) at baseline
HbA1c level in blood
Measured: At baseline, within 7 days before the intervention (observation) starts
Hemoglobin A1c (HbA1c) at follow-up
HbA1c level in blood
Measured: At week 13, within 7 days after the completion of the 12-week intervention (observation)
Fasting insulin at baseline
blood insulin level following overnight (12-h) fasting
Measured: At baseline, within 7 days before the intervention (observation) starts
Fasting insulin at follow-up
blood insulin level following overnight (12-h) fasting
Measured: At week 13, within 7 days after the completion of the 12-week intervention (observation)

Secondary outcomes (19)

Continuous glucose monitoring
14-day continuous glucose monitoring with portable device
Measured: At baseline, within 14 days before the intervention (observation) starts, measurement lasts for 14 days
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)
Measured: At baseline, within 14 days before the intervention (observation) starts, measurement lasts for at least 7 days
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)
Measured: At week 13, within 14 days after the completion of the 12-week intervention (observation), measurement lasts for at least 7 days
Pittsburg sleep quality index (PSQI) at baseline
Pittsburg sleep quality index global (0-21) and sub-scores (0-3), higher score means poorer quality
Measured: At baseline, within 7 days before the intervention (observation) starts
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
Measured: At week 13, within 7 days after the completion of the 12-week intervention (observation)
Height at baseline
height in meters
Measured: At baseline, within 7 days before the intervention (observation) starts
Height at follow-up
height in meters
Measured: At week 13, within 7 days after the completion of the 12-week intervention (observation)
Weight at baseline
weight in kilograms
Measured: At baseline, within 7 days before the intervention (observation) starts
Weight at follow-up
weight in kilograms
Measured: At week 13, within 7 days after the completion of the 12-week intervention (observation)
total cholesterol at baseline
total cholesterol level in blood following overnight (12-h) fasting
Measured: At baseline, within 7 days before the intervention (observation) starts
total cholesterol at follow-up
total cholesterol level in blood following overnight (12-h) fasting
Measured: At week 13, within 7 days after the completion of the 12-week intervention (observation)
triglyceride at baseline
triglyceride level in blood following overnight (12-h) fasting
Measured: At baseline, within 7 days before the intervention (observation) starts
triglyceride at follow-up
triglyceride level in blood following overnight (12-h) fasting
Measured: At week 13, within 7 days after the completion of the 12-week intervention (observation)
non-esterified fatty acid (NEFA) at baseline
morning NEFA level in blood following overnight (12-h) fasting
Measured: At baseline, within 7 days before the intervention (observation) starts
non-esterified fatty acid (NEFA) at follow-up
morning NEFA level in blood following overnight (12-h) fasting
Measured: At week 13, within 7 days after the completion of the 12-week intervention (observation)
IL-6 at baseline
morning interleukin-6 level in blood following overnight (12-h) fasting
Measured: At baseline, within 7 days before the intervention (observation) starts
IL-6 at follow-up
morning interleukin-6 level in blood following overnight (12-h) fasting
Measured: At week 13, within 7 days after the completion of the 12-week intervention (observation)
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.
Measured: At baseline, within 7 days before the intervention (observation) starts
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.
Measured: At week 13, within 7 days after the completion of the 12-week intervention (observation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202130 Jan 2022

First posted1 Jul 2021
Study start1 Jul 2021
Primary completion30 Jan 2022
Study completion30 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by Uppsala UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04946799
Sponsor's protocol ID: HK-LLWYH-202002
Acronym: BLFT
Status last verified: May 2022
First submitted: 31 May 2021
Last updated: 18 May 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Application of Blood Flow Restriction Training in the Exercise Intervention of Chronic Diseases
ClinicalTrials.gov ID: NCT04946799
Acronym / sponsor ID: BLFT / HK-LLWYH-202002
Conditions: Type 2 Diabetes
Keywords: blood flow restriction training, type 2 diabetes, aerobic exercise, randomized-controlled trial
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Uppsala UniversityUniversity, hospital or other
Collaborators: Nanjing Sport Institute, Nanjing Maigaoqiao Community Health Service Center
Study start: 1 Jul 2021 (actual)
Primary completion: 30 Jan 2022 (actual)
Study completion: 30 Jan 2022 (actual)
First posted: 1 Jul 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Objectives:

Study Population:

Randomization:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Low-intensity training combined with blood flow restriction group (LI-BFR)	Experimental	Behavioral: Low-intensity training combined with blood flow restriction (LI-BFR)
High-intensity aerobic exercise group (HI)	Active comparator	Behavioral: High-intensity aerobic exercise (HI)
Low intensity group (LI)	Placebo comparator	Behavioral: Low intensity exercise (LI)

Who may qualify

Ages: 45 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Low-intensity training combined with blood flow restriction group (LI-BFR)
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.	Behavioural	High-intensity aerobic exercise group (HI)
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.	Behavioural	Low intensity group (LI)

Primary outcome

Fasting glucose at baseline
Time frame: At baseline, within 7 days before the intervention (observation) starts
blood glucose level following overnight (12-h) fasting
Fasting glucose at follow-up
Time frame: At week 13, within 7 days after the completion of the 12-week intervention (observation)
blood glucose level following overnight (12-h) fasting
Hemoglobin A1c (HbA1c) at baseline
Time frame: At baseline, within 7 days before the intervention (observation) starts
HbA1c level in blood
Hemoglobin A1c (HbA1c) at follow-up
Time frame: At week 13, within 7 days after the completion of the 12-week intervention (observation)
HbA1c level in blood
Fasting insulin at baseline
Time frame: At baseline, within 7 days before the intervention (observation) starts
blood insulin level following overnight (12-h) fasting
Fasting insulin at follow-up
Time frame: At week 13, within 7 days after the completion of the 12-week intervention (observation)
blood insulin level following overnight (12-h) fasting

19 secondary outcomes

Continuous glucose monitoring
Time frame: At baseline, within 14 days before the intervention (observation) starts, measurement lasts for 14 days
Total sleep duration and total awakening duration at baseline
Time frame: At baseline, within 14 days before the intervention (observation) starts, measurement lasts for at least 7 days
Total sleep duration and total awakening duration at follow-up
Time frame: At week 13, within 14 days after the completion of the 12-week intervention (observation), measurement lasts for at least 7 days
Pittsburg sleep quality index (PSQI) at baseline
Time frame: At baseline, within 7 days before the intervention (observation) starts
Pittsburg sleep quality index (PSQI) at follow-up
Time frame: At week 13, within 7 days after the completion of the 12-week intervention (observation)
Height at baseline
Time frame: At baseline, within 7 days before the intervention (observation) starts
Height at follow-up
Time frame: At week 13, within 7 days after the completion of the 12-week intervention (observation)
Weight at baseline
Time frame: At baseline, within 7 days before the intervention (observation) starts
Weight at follow-up
Time frame: At week 13, within 7 days after the completion of the 12-week intervention (observation)
total cholesterol at baseline
Time frame: At baseline, within 7 days before the intervention (observation) starts
total cholesterol at follow-up
Time frame: At week 13, within 7 days after the completion of the 12-week intervention (observation)
triglyceride at baseline
Time frame: At baseline, within 7 days before the intervention (observation) starts
triglyceride at follow-up
Time frame: At week 13, within 7 days after the completion of the 12-week intervention (observation)
non-esterified fatty acid (NEFA) at baseline
Time frame: At baseline, within 7 days before the intervention (observation) starts
non-esterified fatty acid (NEFA) at follow-up
Time frame: At week 13, within 7 days after the completion of the 12-week intervention (observation)
IL-6 at baseline
Time frame: At baseline, within 7 days before the intervention (observation) starts
IL-6 at follow-up
Time frame: At week 13, within 7 days after the completion of the 12-week intervention (observation)
International Physical Activity Questionnaire - Short Form at baseline
Time frame: At baseline, within 7 days before the intervention (observation) starts
International Physical Activity Questionnaire - Short Form at baseline
Time frame: At week 13, within 7 days after the completion of the 12-week intervention (observation)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yan Zhao, MD, PhD principal investigator

Nanjing Sport Institute

Xiao Tan, PhD study director

Uppsala University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting glucose at baseline (time frame: At baseline, within 7 days before the intervention (observation) starts). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04946799.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.