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
ACTRN12607000240448
Ethics application status
Not yet submitted
Date submitted
5/03/2007
Date registered
7/05/2007
Date last updated
7/05/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Liver and muscle triglyceride and muscle metabolic rate in overweight and type 2 diabetes
Scientific title
Effect of aerobic exercise training on changes in muscle metabolic rate, liver and muscle triglyceride concentration in overweight adults and adults with type 2 diabetes
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 1776 0
Overweight 1777 0
Condition category
Condition code
Mental Health 1863 1863 0 0
Diabetes
Diet and Nutrition 1864 1864 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Four week progressive aerobic exercise training versus sedentary control. Participants will undertake supervised cycle ergometer exercise 4 days per week. Week 1: 30 min per day (as 2 x 15 min bouts at 50% VO2max); Week 2: 45 min per day (as 30 min + 15 min bouts at 50% VO2max); Week 3: 60 min per day (as 2 x 30 min at 60% VO2max); Week 4; 60 min per day (as 2 x 30 min or 60 min continuous at 65% VO2max).
Intervention code [1] 1631 0
Treatment: Other
Comparator / control treatment
Volunteers recruited to the 'sedentary control' group will receive no treatment/intervention as they are healthy individuals.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2645 0
Changes in muscle metabolic rate
Timepoint [1] 2645 0
At 4 weeks relative to baseline
Primary outcome [2] 2646 0
Changes in muscle and liver triglyceride concentration
Timepoint [2] 2646 0
At 4 weeks relative to baseline
Secondary outcome [1] 4497 0
Change in peak aerobic capacity
Timepoint [1] 4497 0
Assessed by incremental exercise test after 4 weeks of training (versus baseline).

Eligibility
Key inclusion criteria
Inclusion for overweight and type 2 diabetes groups: Body mass index (BMI)>25 kg/m2 with or without type 2 diabetes.
Inclusion for lean non-diabetic group = BMI < 25.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
BMI>30, advanced cardiovascular disease, musculoskeletal ailment

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2011 0
Commercial sector/Industry
Name [1] 2011 0
Nestle
Country [1] 2011 0
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 1822 0
Commercial sector/Industry
Name [1] 1822 0
Rayscan Imaging Liverpool
Address [1] 1822 0
Country [1] 1822 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3739 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 3739 0
Ethics committee country [1] 3739 0
Australia
Date submitted for ethics approval [1] 3739 0
Approval date [1] 3739 0
Ethics approval number [1] 3739 0

Summary
Brief summary
3 groups of individuals will be recruited for the research: a. lean healthy individuals b. overweight individuals with type 2 diabetes c. overweight (matched to b) non-diabetic individuals. All groups will be assessed and compared for muscle and liver triglyceride concentration and muscle metabolic rate to address the hypothesis that overweight and/or type 2 diabetes is associated with low metabolic rate and elevated liver and muscle triglyceride content. Individuals in groups b and c will then undertake 4 weeks of aerobic exercise training to determine if training influences these metabolic 'abnormalities'. This will be determined by comparing these measures AFTER 4 training weeks with those determined PRE-TRAINING.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27565 0
Address 27565 0
Country 27565 0
Phone 27565 0
Fax 27565 0
Email 27565 0
Contact person for public queries
Name 10820 0
Dr Nathan Johnson
Address 10820 0
Faculty of Health Sciences
University of Sydney
East St
Lidcombe NSW 2141
Country 10820 0
Australia
Phone 10820 0
+61 2 93519137
Fax 10820 0
Email 10820 0
[email protected]
Contact person for scientific queries
Name 1748 0
Dr Nathan Johnson
Address 1748 0
Faculty of Health Sciences
University of Sydney
East St
Lidcombe NSW 2141
Country 1748 0
Australia
Phone 1748 0
+61 2 93519137
Fax 1748 0
Email 1748 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
No additional documents have been identified.