Type 2 Diabetes
Conditions
Keywords
blood flow restriction training, type 2 diabetes, aerobic exercise, randomized-controlled trial
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).
Interventions
BEHAVIORALLow-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.
BEHAVIORALHigh-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.
BEHAVIORALLow 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.
Sponsors
Nanjing Sport Institute
Nanjing Maigaoqiao Community Health Service Center
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting glucose at baseline | At baseline, within 7 days before the intervention (observation) starts | blood glucose level following overnight (12-h) fasting |
| Fasting glucose at follow-up | 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 | At baseline, within 7 days before the intervention (observation) starts | HbA1c level in blood |
| Hemoglobin A1c (HbA1c) at follow-up | At week 13, within 7 days after the completion of the 12-week intervention (observation) | HbA1c level in blood |
| Fasting insulin at baseline | At baseline, within 7 days before the intervention (observation) starts | blood insulin level following overnight (12-h) fasting |
| Fasting insulin at follow-up | At week 13, within 7 days after the completion of the 12-week intervention (observation) | blood insulin level following overnight (12-h) fasting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Height at follow-up | At week 13, within 7 days after the completion of the 12-week intervention (observation) | height in meters |
| Weight at baseline | At baseline, within 7 days before the intervention (observation) starts | weight in kilograms |
| Weight at follow-up | At week 13, within 7 days after the completion of the 12-week intervention (observation) | weight in kilograms |
| total cholesterol at baseline | At baseline, within 7 days before the intervention (observation) starts | total cholesterol level in blood following overnight (12-h) fasting |
| total cholesterol at follow-up | At week 13, within 7 days after the completion of the 12-week intervention (observation) | total cholesterol level in blood following overnight (12-h) fasting |
| triglyceride at baseline | At baseline, within 7 days before the intervention (observation) starts | triglyceride level in blood following overnight (12-h) fasting |
| Continuous glucose monitoring | At baseline, within 14 days before the intervention (observation) starts, measurement lasts for 14 days | 14-day continuous glucose monitoring with portable device |
| non-esterified fatty acid (NEFA) at baseline | At baseline, within 7 days before the intervention (observation) starts | morning NEFA level in blood following overnight (12-h) fasting |
| non-esterified fatty acid (NEFA) at follow-up | At week 13, within 7 days after the completion of the 12-week intervention (observation) | morning NEFA level in blood following overnight (12-h) fasting |
| IL-6 at baseline | At baseline, within 7 days before the intervention (observation) starts | morning interleukin-6 level in blood following overnight (12-h) fasting |
| IL-6 at follow-up | At week 13, within 7 days after the completion of the 12-week intervention (observation) | morning interleukin-6 level in blood following overnight (12-h) fasting |
| International Physical Activity Questionnaire - Short Form at baseline | At baseline, within 7 days before the intervention (observation) starts | 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. |
| triglyceride at follow-up | At week 13, within 7 days after the completion of the 12-week intervention (observation) | triglyceride level in blood following overnight (12-h) fasting |
| 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 (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 | At week 13, within 14 days after the completion of the 12-week intervention (observation), measurement lasts for at least 7 days | 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 | At baseline, within 7 days before the intervention (observation) starts | 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 | At week 13, within 7 days after the completion of the 12-week intervention (observation) | Pittsburg sleep quality index global (0-21) and sub-scores (0-3), higher score means poorer quality |
| Height at baseline | At baseline, within 7 days before the intervention (observation) starts | height in meters |
Countries
China
Outcome results
None listed