Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617001264370
Ethics application status
Approved
Date submitted
28/08/2017
Date registered
1/09/2017
Date last updated
12/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of external counterpulsation on blood glucose control in participants with type 2 diabetes
Scientific title
Effects of external counterpulsation on blood glucose control in participants with type 2 diabetes
Secondary ID [1] 292756 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 2 diabetes 304546 0
Condition category
Condition code
Metabolic and Endocrine 303867 303867 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 298991 0
Treatment: Devices
Comparator / control treatment
Sham treatment involves the participant lying on a bed with cuffs around the legs and hips. It is sham because the cuffs do not inflate and deflate.
The sessions will take place at The University of Queensland, St Lucia and will be provided by a trained technician.
Control group
Placebo

Outcomes
Primary outcome [1] 303222 0
HbA1c using serum samples
Timepoint [1] 303222 0
7 weeks
Secondary outcome [1] 338272 0
HOMA2 beta cell function (%B) value calculated using fasting plasma glucose and insulin values taken from a blood test
Timepoint [1] 338272 0
7 weeks
Secondary outcome [2] 338273 0
HOMA2 insulin sensitivity (%S) value calculated using fasting plasma glucose and insulin values taken from a blood test
Timepoint [2] 338273 0
7 weeks
Secondary outcome [3] 338274 0
HOMA2 insulin resistance (IR) value calculated using fasting plasma glucose and insulin values taken from a blood test
Timepoint [3] 338274 0
7 weeks
Secondary outcome [4] 338275 0
Basal Disposition Index calculated using fasting plasma glucose and insulin values taken from a blood test
Timepoint [4] 338275 0
7 weeks
Secondary outcome [5] 338276 0
Cardiorespiratory Fitness (VO2peak) as a measure of exercise capacity using a graded exercise test to exhaustion with expired air measured using a metabolic system.
Timepoint [5] 338276 0
7 weeks
Secondary outcome [6] 338277 0
Central Mean Arterial Pressure as a measure of vascular structure using a SpyhgmoCor pulse wave analysis/velocity machine
Timepoint [6] 338277 0
7 weeks
Secondary outcome [7] 338278 0
Pulse Wave Velocity using a SpyhgmoCor pulse wave analysis/velocity machine
Timepoint [7] 338278 0
7 weeks
Secondary outcome [8] 338279 0
Flow Mediated Dilation of the Brachial Artery following ischemia as a measure of vascular function measured using vascular ultrasound
Timepoint [8] 338279 0
7 weeks
Secondary outcome [9] 338319 0
Markers of oxidative stress and inflammation (nitrate, nitrite, F2-isoprostanes, protein carbonyls, C reactive protein, IL-6, IL-10, IL-ra and thrombospondin-2) in plasma/serum taken from a blood test
Timepoint [9] 338319 0
7 weeks

Eligibility
Key inclusion criteria
Diagnosis of Type 2 Diabetes
Minimum age
25 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2017
Actual
10/10/2017
Date of last participant enrolment
Anticipated
31/01/2018
Actual
31/01/2018
Date of last data collection
Anticipated
31/03/2018
Actual
1/06/2018
Sample size
Target
45
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 297391 0
Commercial sector/Industry
Name [1] 297391 0
Renew Group
Country [1] 297391 0
Singapore
Primary sponsor type
Individual
Name
Jeff Coombes
Address
School of HMNS, Blair Drive, University of Queensland, St Lucia 4072, AUSTRALIA
Country
Australia
Secondary sponsor category [1] 296389 0
None
Name [1] 296389 0
Address [1] 296389 0
Country [1] 296389 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298490 0
University of Queensland Human Research Ethics Committee
Ethics committee address [1] 298490 0
Cumbrae-Stewart Building (72), Research Road, University of Queensland, St Lucia 4072.
Ethics committee country [1] 298490 0
Australia
Date submitted for ethics approval [1] 298490 0
Approval date [1] 298490 0
24/05/2016
Ethics approval number [1] 298490 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77254 0
Prof Jeff Coombes
Address 77254 0
School of HMNS, Blair Drive, University of Queensland, St Lucia, 4072
Country 77254 0
Australia
Phone 77254 0
+61733656767
Fax 77254 0
Email 77254 0
[email protected]
Contact person for public queries
Name 77255 0
Dr Llion Roberts
Address 77255 0
School of HMNS, Blair Drive, University of Queensland, St Lucia, 4072
Country 77255 0
Australia
Phone 77255 0
+61733656445
Fax 77255 0
Email 77255 0
[email protected]
Contact person for scientific queries
Name 77256 0
Prof Jeff Coombes
Address 77256 0
School of HMNS, Blair Drive, University of Queensland, St Lucia, 4072
Country 77256 0
Australia
Phone 77256 0
+61733656767
Fax 77256 0
Email 77256 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEfficacy of two doses of external counterpulsation (ECP) on glycemic control in people with type 2 diabetes mellitus: A randomized SHAM-controlled trial.2023https://dx.doi.org/10.1016/j.diabres.2023.110701
N.B. These documents automatically identified may not have been verified by the study sponsor.