Type 2 Diabetes
Conditions
Keywords
Tai Ji, Diabetes Mellitus, Type 2, Blood Glucose, Cross-Over Studies, Vascular Stiffness, Endothelium, Vascular
Brief summary
Type 2 diabetes mellitus (T2DM) in the elderly population is associated with compromised cardiovascular and metabolic functions, thereby necessitating the implementation of safe exercise interventions. This study employs a randomized, single-blind, crossover design will be conducted in Brazil to examine whether Tai Chi, a low-impact mind-body exercise, offers acute benefits comparable to those of moderate-intensity combined exercise (MICE) in 24 older adults (≥65 years) diagnosed with T2DM, consisting of 12 men and 12 women. Participants recruited through community advertisements and screened to ensure inactivity, stable medication usage, and the absence of significant comorbidities will undergo randomized sessions of Tai Chi, MICE, and a control (CON) intervention. Evaluations will include capillary blood glucose (the primary outcome), blood pressure, heart rate variability, arterial stiffness (PWVcf), and endothelial function (FMD) measured before, immediately after, and 45minute post-intervention, along with 24-hour ambulatory monitoring. Standardized protocols will be employed to regulate physical activity. By juxtaposing these interventions, the study seeks to ascertain if Tai Chi could serve as a feasible alternative for enhancing acute metabolic and cardiovascular responses in older diabetic adults, thus providing practical insights for clinical and lifestyle management.
Interventions
OTHERTai Chi
Yang style of Tai Chi (24 form)
start from warm up (5 minute )repetitions in circuit in the exercises bent row with elastic band, bodyweight squats, adapted push-ups (on the wall or on the counter), deadlifts with an elastic band, presses with an elastic band and an abdominal band on the floor or adapted on the chair and cool down in the end
The CON session will last 60 minutes and will be conducted only sitting. Participants will be told not to sleep and will not be allowed to use reading materials or any electrical gadgets during the CON session.
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
Universidade Estadual Paulista Júlio de Mesquita Filho
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Crossover Model (All participants will get all interventions in random order: Tai Chi, MICE, and control.)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
only with type 2 diabetes
Exclusion criteria
* if not able to perform physical exercise (Extreme neuropathy, wounds in the feet, and amputation risk.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Capillary blood glucose change from baseline | Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105) | Capillary blood glucose will be measured using a digital glucometer (FreeStyle Optium Neo, 163 Abbott, Oxon, UK) in milligrams per deciliter (mg/dL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Carotid-femoral pulse wave velocity (PWVcf) change from baseline | Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105) | Carotid-femoral pulse wave velocity (PWVcf) will be measured using an automated device (Complior Analyze™ PWV and Central Pressure Analysis™; AlamMedical, Saint-Quentin-Fallavier, France), in meters per second (m/s) |
| Brachial artery flow-mediated dilation (FMD) change from baseline | Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105) | Brachial artery flow-mediated dilation (FMD) will be measured using an ultrasound device (SonoSite M-Turbo™; Fujifilm Inc., Bothell, Washington, USA), and will consist in the brachial artery diameter difference between before (baseline diameter) and after (peak diameter) the artery occlusion for 5 minutes. FMD will be expressed in percentage (%) and will be determined by the following formula: FMD (%) = (peak diameter - baseline diameter)/baseline diameter × 100 |
| Central blood pressures change from baseline | Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105) | Central blood pressures will be assessed directly from the carotid pressure waveform, in millimeters of mercury (mmHg), and using a non-invasive automated device (Complior Analyze™ PWV and Central Pressure Analysis™; AlamMedical, Saint-Quentin-Fallavier, France) |
| Heart rate variability (HRV) change from baseline | Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105) | Heart rate variability will be assesseded using a digital telemetry system (Polar H10™, Polar Electro Inc, Kempele, Finland) to measure HR signals beat-to-beat. A sequence of 256 stable R-R intervals will be used to calculate frequency and time domain indexes, in hertz (Hz) and milliseconds (ms), respectively |
| 24-hour ambulatory blood pressure monitoring (ABPM) difference between interventions | 24 hours | Ambulatory systolic and diastolic blood pressure monitoring (ABPM), in millimeters of mercury (mmHg), will be measured for 24 hours after the end of each visit (approximately 90 minutes after the end of the Tai Chi, moderate-intensity combined exercise and control interventions), after a brief bath and using an automatic equipment (CardioMapa™, Cardios Sistemas Comercial e Industrial Ltda., São Paulo, Brazil). |
| 24-hour heart rate variability (HRV) difference between interventions | 24 hours | Ambulatory heart rate variability (HRV) will be assessed for 24 hours after the end of each visit (approximately 90 minutes after the end of the Tai Chi, moderate-intensity combined exercise and control interventions), after a brief bath and using an automatic equipment (CardioMapa™, Cardios Sistemas Comercial e Industrial Ltda., São Paulo, Brazil). The will measure the heart rhythm (3-lead electrocardiogram), and the R-R intervals will be used to calculate frequency and time domain indexes, in hertz (Hz) and milliseconds (ms), respectively |
| Brachial blood pressure (BP) change from baseline | Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105) | Systolic and diastolic brachial blood pressure (BP) will be measured using an automatic monitor (Omron HEM 7200™, Omron Healthcare Inc., Dalian, China) in millimeters of mercury (mmHg) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Augmentation Index (AIx) change from baseline | Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105) | Derived from central pressure waveforms via Complior Analyze™. Calculated as: \[(Second systolic peak - First systolic peak) / Pulse pressure\] × 100. Reported in %. |
| Heart rate change from baseline | Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105) | Heart rate will be measured using a digital telemetry system (Polar H10™, Polar Electro Inc, Kempele, Finland) in beats per minute (bpm) |
Contacts
Primary ContactEmmanuel Gomes Ciolac, PhD
Backup ContactJunaid Riaz, Master
Outcome results
None listed