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

NCT04946799 | Completed

• 1 other identifier: HK-LLWYH-202002
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

blood flow restriction training; type 2 diabetes; aerobic exercise; randomized-controlled trial

Outcome Measures

Primary Outcomes (6)

• Fasting glucose at baseline

  blood glucose level following overnight (12-h) fasting

  At baseline, within 7 days before the intervention (observation) starts

• 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)

• Hemoglobin A1c (HbA1c) at baseline

  HbA1c level in blood

  At baseline, within 7 days before the intervention (observation) starts

• 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)

• Fasting insulin at baseline

  blood insulin level following overnight (12-h) fasting

  At baseline, within 7 days before the intervention (observation) starts

• 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 Outcomes (19)

• Continuous glucose monitoring

  At baseline, within 14 days before the intervention (observation) starts, measurement lasts for 14 days

• Total sleep duration and total awakening duration at baseline

  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

  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

  At baseline, within 7 days before the intervention (observation) starts

• Pittsburg sleep quality index (PSQI) at follow-up

  At week 13, within 7 days after the completion of the 12-week intervention (observation)

Study Arms (3)

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)

Interventions

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

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.

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

High-intensity aerobic exercise (HI) BEHAVIORAL

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.

High-intensity aerobic exercise group (HI)

Low intensity exercise (LI) BEHAVIORAL

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.

Low intensity group (LI)

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead
• Nanjing Sport Institute: collaborator
• Nanjing Maigaoqiao Community Health Service Center: collaborator

Study Sites (1)

Nanjing Maigaoqiao Community Healthcare Center

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Yan Zhao, MD, PhD

  Nanjing Sport Institute

  PRINCIPAL INVESTIGATOR

• Xiao Tan, PhD

  Uppsala University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: July 1, 2021
• Study Start: July 1, 2021
• Primary Completion: January 30, 2022
• Study Completion: January 30, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)