Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000131358
Ethics application status
Not yet submitted
Date submitted
29/02/2008
Date registered
13/03/2008
Date last updated
13/03/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Bone and type 2 diabetes: effects of power and aerobic exercise
Scientific title
Bone and type 2 diabetes: effects of power and aerobic exercise
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy females 2894 0
Type 2 diabetes 2916 0
Condition category
Condition code
Metabolic and Endocrine 3029 3029 0 0
Diabetes
Metabolic and Endocrine 3049 3049 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase One: cross-sectional comparison between females with and without type 2 diabetes mellitus (T2DM)

Phase Two: the effects of a single 45 minute exercise session (aerobic or power exercises) on plasma uncarboxylated osteocalcin (unc-OC), adionectine (AN) and c-peptide. Blood samples will be taken before exercise, immediately after and at 0.5, 1, 2, 24 and 48 hours post exercise.

Phase Three: Participants will be randomised to six months of either power training or aerobic training (each session will be 60 minutes, 3 sessions per week) and 12 months of follow-up
Intervention code [1] 2624 0
Rehabilitation
Comparator / control treatment
N/A
Control group
Active

Outcomes
Primary outcome [1] 3910 0
Uncarboxylated osteocalcin (unc-OC) will be
analysed based on a sandwich type electro-chemiluminescence immunoassay (ECLIA) utilizing anti-OCG3 mouse monoclonal antibody labelled with Ruthenium (Ru) which luminates with electric stimuli. Magnetic beads bound to anti GluOC 4-5 mouse monoclonal antibody is used as a solid phase. After binding the unc-OC in the sample with the GluOC4-5 bound beads and Ru labelled OCG3, an electric impulse is applied via an electrode. The level of luminescence for the Ru complexes bound to solid phase antibody reflects the amount of unc-OC in the sample. The concentration of the unc-OC in the sample is measured by comparing the sample's luminescence to that of a calibrated solution of known unc-OC standards
Timepoint [1] 3910 0
Baseline, 3, 6 and 18 months
Secondary outcome [1] 6585 0
Clinical outcomes (lipids and fasting glucose will be analysed using SYNCHRON LX System/Lxi725, Beckman Coulter Inc, CA, USA) )
Anthropometric measurements (fat, muscle and bone density (using Dual-energy X-ray absorptiometry, DXA)
Functional capacity (physical performance test)
Quality of life (SF-36 and the cardiac depression scale, CDS).
Timepoint [1] 6585 0
Baseline, 3, 6 and 18 months

Eligibility
Key inclusion criteria
Inclusion criteria for the non-diabetic group: the non-diabetic group will be matched for age, body mass index (BMI) and menopausal status to the diabetic group and will have fasting blood glucose < 5.6 mmol/L.

Inclusion criteria for individuals with T2DM: Volunteers with fasting plasma glucose =7.0 mmol/L ("Report of the expert committee on the diagnosis and classification of diabetes mellitus," 2003) and with HbA1C<8% will be included. In addition, volunteers treated with diet alone and/or use stable doses of metformin for at least 3 months will be included.
Minimum age
35 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for the non-diabetic group. Fasting blood glucose <5.6 mmol/L, or individuals who are unable to exercise. In addition, participants who are already involved in regular vigorous physical training in the preceding 6 months.

Exclusion criteria individuals with T2DM. Individuals with unstable T2DM, individuals on sulfonylureas or insulin therapy and individuals who have participated in regular vigorous resistance training in the preceding 6 months will be excluded from the study. Also, patients unable to exercise will be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Females will be divided into two groups (a) non-diabetic, and (b) diabetic. The non-diabetic group will be matched to the T2DM group for age and menopausal status.
Each group (i.e. T2DM and non-diabetics) will then be randomly allocated (sealed opaque envelops) into power or aerobic training groups (i.e. T2DM power and T2DM aerobic and non-diabetic power and non-diabetic aerobic). Randomization will be stratified according to pre/post menopause to ensure a similar number of pre menopause and post menopause females in each subgroup.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method of randomisation for this study is Stratified allocation. The randomisation is according to menopausal state. There will be two different sets of sealed envelopes for those with T2DM and those without T2DM.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 783 0
3011

Funding & Sponsors
Funding source category [1] 3144 0
University
Name [1] 3144 0
Victoria University
Country [1] 3144 0
Australia
Funding source category [2] 3167 0
University
Name [2] 3167 0
Victoria University
Country [2] 3167 0
Australia
Funding source category [3] 3168 0
University
Name [3] 3168 0
Victoria University
Country [3] 3168 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
School of Human Movement, Recreation & Performance
Victoria University
Ballart Rd
PO Box 14428
Footscray Melbourne VIC 8001
Country
Australia
Secondary sponsor category [1] 2822 0
Hospital
Name [1] 2822 0
Austin Health
Address [1] 2822 0
Austin Health
Repatriation Campus
Waterdale Road
Heidelberg West Melbourne VIC 3081
Country [1] 2822 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5121 0
Ethics committee address [1] 5121 0
Ethics committee country [1] 5121 0
Date submitted for ethics approval [1] 5121 0
11/03/2008
Approval date [1] 5121 0
Ethics approval number [1] 5121 0
Ethics committee name [2] 5147 0
Ethics committee address [2] 5147 0
Ethics committee country [2] 5147 0
Date submitted for ethics approval [2] 5147 0
11/03/2008
Approval date [2] 5147 0
Ethics approval number [2] 5147 0
Ethics committee name [3] 5148 0
Ethics committee address [3] 5148 0
Ethics committee country [3] 5148 0
Date submitted for ethics approval [3] 5148 0
11/03/2008
Approval date [3] 5148 0
Ethics approval number [3] 5148 0

Summary
Brief summary
This study will examine the links between bone structure and metabolism, type 2 diabetes (T2DM) and exercise. First, we aim to test the hypothesis that bone is implicated in the pathogenesis of T2DM through mechanisms involving osteocalcin (OC) in its uncarboxylated (unc-OC) form. Second, we aim to examine the acute and chronic effects of a novel form of exercise training for people with T2DM, power training, and compare it to aerobic training on osteocalcin-mediated effects on glucose metabolism in females with and without T2DM.

Hypotheses

Phase One: Bone structural abnormalities are present in patients with T2DM, compared to non-diabetic individuals matched for aged, body mass index (BMI), although bone mineral density (BMD) is high.

Phase 2: Acute effects of exercise: In both non-diabetic females and those with T2DM, power exercise will result in greater increases in unc-OC and high molecular weight (HMW)-adiponectin (AN) levels, compared to the acute effects of aerobic exercise.

Phase 3 Chronic effects of exercise: In both non-diabetic females and those with T2DM, power training will result in greater improvements in bone structural strength and a shift of bone remodelling balance towards greater formation than for aerobic exercise training.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28415 0
Address 28415 0
Country 28415 0
Phone 28415 0
Fax 28415 0
Email 28415 0
Contact person for public queries
Name 11572 0
Itamar Levinger
Address 11572 0
School of Human Movement, Recreation & Performance
Victoria University
Ballart Rd
PO Box 14428
Footscray Melbourne VIC 3011
Country 11572 0
Australia
Phone 11572 0
+61 3 99194499
Fax 11572 0
Email 11572 0
[email protected]
Contact person for scientific queries
Name 2500 0
Itamar Levinger
Address 2500 0
School of Human Movement, Recreation & Performance
Victoria University
Ballart Rd
PO Box 14428
Footscray Melbourne VIC 3011
Country 2500 0
Australia
Phone 2500 0
+61 3 99194499
Fax 2500 0
Email 2500 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

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