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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]

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

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Metabolic and Endocrine

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]

Rehabilitation

Intervention code [2]

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]

Microcirculatory endothelial function will be assessed on forearm skin by Laser Speckle Contrast Imaging incorporating transdermal iontophoresis of vasoactive drugs (Acetylcholine, Insuline).

Timepoint [1]

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]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment postcode(s) [1]

3065 - Fitzroy

Funding & Sponsors

Funding source category [1]

University

Name [1]

Australian Catholic University

Address [1]

115 Victoria Parade, Fitzroy VIC 3065

Country [1]

Australia

Primary sponsor type

University

Name

Australian Catholic University

Address

115 Victoria Parade, Fitzroy VIC 3065

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Australian Catholic University

Ethics committee address [1]

115 Victoria Parade, Fitzroy VIC 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

18/03/2014

Ethics approval number [1]

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

Prof Geraldine NAUGHTON

Address

Australian Catholic University
School of Exercise Sciences
115 Victoria Parade, Fitzroy VIC 3065

Country

Australia

Phone

+61 03 99533034

Fax

geraldine.naughton@acu.edu.au

Contact person for public queries

Name

Guillaume WALTHER

Address

Australian Catholic University
School of Exercise Sciences
115 Victoria Parade, Fitzroy VIC 3065

Country

Australia

Phone

+61 03 99533954

Fax

guillaume.walther@univ-avignon.fr

Contact person for scientific queries

Name

Guillaume WALTHER

Address

Australian Catholic University
School of Exercise Sciences
115 Victoria Parade, Fitzroy VIC 3065

Country

Australia

Phone

+61 03 99533954

Fax

guillaume.walther@univ-avignon.fr

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

Source	Title	Year of Publication	DOI
Embase	Effects of Sugar-Sweetened Beverage Consumption on Microvascular and Macrovascular Function in a Healthy Population.	2017	https://dx.doi.org/10.1161/ATVBAHA.116.308010

N.B. These documents automatically identified may not have been verified by the study sponsor.

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