Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
ACTRN12614000614695
Ethics application status
Approved
Date submitted
29/05/2014
Date registered
6/06/2014
Date last updated
17/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Can physical activity prevent the associated vascular dysfunction in type 2 diabetes?
Scientific title
Effect of physical activity on endothelial function in healthy adults and in adults with Type 2 diabetes
Secondary ID [1] 284695 0
Nil known
Universal Trial Number (UTN)
U1111-1157-5021
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 292049 0
Condition category
Condition code
Cardiovascular 292385 292385 0 0
Other cardiovascular diseases
Metabolic and Endocrine 292409 292409 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We propose a randomized crossover design study to investigate micro-circulatory endothelial and smooth muscle cell function in response to sugary drink, insulin resistance and combinations of these factors with physical activity in healthy and type 2 diabetes (T2D) participants.

Microvascular investigation will be performed before and after a 12-week exercise program (see details below). Participants will present to the laboratory following overnight fasting. All measurements will be taken before (baseline) and 15 min after sugary drink ingestion (65 g of sugar for a 600 mL drink to challenge vascular function) or placebo drink in a randomized order for each volunteer (5 days between consumption of both drinks). A period of 15 min after drink ingestion is chosen because pilot research demonstrated that plasma glucose and insulin concentrations reach peak values within 15–30 min after glucose loading via sugary drink ingestion.

In the week following pre-intervention microvascular measurements, participants will begin a 12-week vigorous exercise program in-line with ESSA guidelines (Hordern et al., 2012). T2D participants will be randomized into two groups identified as Group 1 and Group 2. Initially, Group 2 (control) participants will not participate in any physical activity outside of usual activities of daily living, whilst Group 1 will participate in a 12 week vigorous exercise program. To achieve the minimum of 125 minutes vigorous exercise per week, participants will attend three supervised 60 minute training sessions per week in small group sessions (up to 5 participants). Each training session will be comprised of vigorous aerobic training and resistance exercises and administrated all time by an exercise physiologist. Sessions will include a 10 minute warm up period at 60-70% peak heart rate on the Monark Cycle. The main exercise session will begin with 20 minutes of a whole-body resistance training circuit. Participants will spend 45 seconds at each station and a have a maximum of 15 seconds to move between the 5 stations. Resistance will be set at the participant’s individual 10 maximal repetition (RM). Each participant’s 10RM will be determined in the week prior to the intervention. Resistance will be adjusted throughout the intervention by use of a rating of perceived exertion (RPE). Following the resistance training circuit, participants will perform a 22 minute bout of continuous cycling at 80% peak heart rate. Participants will wear heart rate monitors to achieve the assigned exercise intensity.
Intervention code [1] 289484 0
Rehabilitation
Intervention code [2] 289503 0
Lifestyle
Comparator / control treatment
Group 2 will have exercise intervention after 12 weeks, whilst Group 1 participant’s will not perform any physical activity outside daily living to investigate the effects of detraining and maintenance.
Control group
Active

Outcomes
Primary outcome [1] 292245 0
Microcirculatory endothelial function will be assessed on forearm skin by Laser Speckle Contrast Imaging incorporating transdermal iontophoresis of vasoactive drugs (Acetylcholine, Insuline).
Timepoint [1] 292245 0
End of intervention (12 weeks after participants started the physical activity program) and end of detraining period (week 24, 12 weeks after participants ended the physical activity program).
Secondary outcome [1] 308528 0
Microcirculatory smooth muscle cell function will be assessed on forearm skin by Laser Speckle Contrast Imaging incorporating transdermal iontophoresis of vasoactive drug (sodium nitroprusside).
Timepoint [1] 308528 0
End of intervention (12 weeks after participants started the physical activity program) and end of detraining period (week 24, 12 weeks after participants ended the physical activity program).

Eligibility
Key inclusion criteria
60 participants aged 18-65 years old will be recruited: 30 healthy sedentary (< 2 hours of scheduled physical activity per week) controls, and 30 sedentary T2D patients. Participants will be matched on age, sex and BMI of T2D participants, to focus on the specific effect of T2D.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded based on any of the following: cardiovascular disease or history, smoking, more than 5% weight gain or loss in the last 6 months; or use of vasodilator medication.

Study design
Purpose of the study
Educational / counselling / training
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/06/2014
Actual
9/06/2014
Date of last participant enrolment
Anticipated
1/07/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2518 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 8209 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 289317 0
University
Name [1] 289317 0
Australian Catholic University
Country [1] 289317 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
115 Victoria Parade, Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 287988 0
None
Name [1] 287988 0
Address [1] 287988 0
Country [1] 287988 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291080 0
Australian Catholic University
Ethics committee address [1] 291080 0
115 Victoria Parade, Fitzroy VIC 3065
Ethics committee country [1] 291080 0
Australia
Date submitted for ethics approval [1] 291080 0
Approval date [1] 291080 0
18/03/2014
Ethics approval number [1] 291080 0
2014 02V

Summary
Brief summary
The incidence of type 2 diabetes mellitus (T2DM) is growing rapidly, in part because of the aging population, sedentary lifestyle and diet habits. In 2010, an estimated 257 million people worldwide had T2DM, representing an important global public health issue. Non-healthy diet is commonly accompanied by consumption of sugar-sweetened beverages (SSB), reported to provide little (if any) other nutrition or health benefit. The last 2010 National Nutrition Survey in Australia found that 58% of young adults drink an average of 2.1 cans per day (800mL), which is the first everyday source of sugar. In this context, several studies reported in children and adults high correlation between SSB consumption and risk to develop T2DM due to its effects on weight gain and glucose metabolism. These drinks represent 70 to 120g of sugar per litre and lead to acute transient hyperglycaemia (high level of glucose in blood), reported as a precursor of insulin-resistance but also responsible of endothelial dysfunction in the whole arterial tree. The endothelium is the thin layer of cells that lines the interior surface of heart and blood vessels and helps to control blood pressure through vasodilation and vasoconstriction, the widening and constricting of the blood vessels respectively. However, very few studies have investigated the underlying mechanisms involved in endothelial dysfunction in response to SSB -induced acute hyperglycemia. Briefly, endothelial dysfunction in this context has been demonstrated as an impairment of the capacity of blood vessels vasodilation, probably associated with a reduction in nitric oxide (NO) synthesis or biodisponibility. Previous results from our team has reported for the first time in cutaneous microcirculation the implication of oxidative stress and lower activity of endothelial nitric oxide synthase (eNOS, which is responsible of NO synthesis) in endothelial dysfunction after an acute hyperglycemia in healthy rats. On the top that, our works and other demonstrated that patients with T2M or patients in pre-diabetic state (obese or metabolic syndrome) have chronic NO related endothelial dysfunction even without environmental stress. Thus, the first objective of the present study is to explore the effect of SSB consumption on endothelial function in large as well as in small vessels in healthy and T2M subjects, with a focus on underlying mechanisms of the NO pathway. To improve cardiovascular dysfunction in several diseases, physical exercise is a well-known non pharmacological strategy. The higher antioxidant status in cardiovascular and muscular tissues are likely to account for the positive effects of this strategy for disease prevention or rehabilitation. Physical Exercise exercise training is also reported to improve the NO pathway with higher eNOS expression. Thus, the second objective of the present work will be to investigate the potential preventive effects of physical activity on endothelial dysfunction following acute hyperglycemia in healthy and T2DM participants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48826 0
Prof Geraldine NAUGHTON
Address 48826 0
Australian Catholic University
School of Exercise Sciences
115 Victoria Parade, Fitzroy VIC 3065
Country 48826 0
Australia
Phone 48826 0
+61 03 99533034
Fax 48826 0
Email 48826 0
[email protected]
Contact person for public queries
Name 48827 0
Guillaume WALTHER
Address 48827 0
Australian Catholic University
School of Exercise Sciences
115 Victoria Parade, Fitzroy VIC 3065
Country 48827 0
Australia
Phone 48827 0
+61 03 99533954
Fax 48827 0
Email 48827 0
[email protected]
Contact person for scientific queries
Name 48828 0
Guillaume WALTHER
Address 48828 0
Australian Catholic University
School of Exercise Sciences
115 Victoria Parade, Fitzroy VIC 3065
Country 48828 0
Australia
Phone 48828 0
+61 03 99533954
Fax 48828 0
Email 48828 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
EmbaseEffects of Sugar-Sweetened Beverage Consumption on Microvascular and Macrovascular Function in a Healthy Population.2017https://dx.doi.org/10.1161/ATVBAHA.116.308010
N.B. These documents automatically identified may not have been verified by the study sponsor.