None listed
Conditions
Brief summary
A three-group, randomised, placebo-controlled trial will be performed. Forty five participants with type 2 diabetes will be assigned to either 1) ECP30: ECP therapy for 30 mins/session or 2) ECP45: ECP therapy for 45 mins/session or 3) placebo (sham). Each participant will have 3 ECP/sham sessions/week for 7 weeks. To assess the effectiveness of the ECP therapy before and after the 7-week intervention participants will undergo tests of cardiorespiratory fitness, exercise capacity, blood markers (HOMA values and basal disposition index using fasting glucose and insulin), HbA1c, nitrate, nitrite, F2-isoprostanes, protein carbonyls, C reactive protein, IL-6, IL-10, IL-ra and thrombospondin-2) and vascular structure and function.
Interventions
Two intervention arms corresponding to 30 mins and 45 mins of external counterpulsation (ECP)treatment per session. Participants in both intervention arms will have 3 sessions/week for 7 weeks.
Treatment involves the participant lying on a bed with cuffs around the legs and hips. The ECP treatment involves the cuffs inflating and deflating every few seconds to change the blood flow returning to the heart.
The sessions will take place at The University of Queensland, St Lucia and will be provid
Two intervention arms corresponding to 30 mins and 45 mins of external counterpulsation (ECP)treatment per session. Participants in both intervention arms will have 3 sessions/week for 7 weeks. Treatment involves the participant lying on a bed with cuffs around the legs and hips. The ECP treatment involves the cuffs inflating and deflating every few seconds to change the blood flow returning to the heart. The sessions will take place at The University of Queensland, St Lucia and will be provided by a trained technician. Intervention adherence will be assessed as the number of visits attended from the 21 possible.
Sponsors
Jeff Coombes
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
25 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Diagnosis of Type 2 Diabetes
Exclusion criteria
History of deep vein thrombosis, phlebitis, stasis ulcer, or pulmonary embolism; Uncontrolled hypertension or systemic hypotension; Cardiac arrhythmia that would interfere with ECG synchronisation of ECP; Severe heart failure; Aortic valve insufficiency, regurgitation, dissection, or aneurysm; Recent illness or heart catheterizations within the past 3 months; Acute coronary syndrome; Diagnosed glaucoma; Pregnancy.
Outcome results
None listed