Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000436572
Ethics application status
Approved
Date submitted
24/09/2006
Date registered
11/10/2006
Date last updated
16/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial examining the effects of progressive resistance training on insulin resistance and body composition in
older adults with type 2 diabetes and metabolic syndrome
Scientific title
A randomised controlled trial examining the effects of progressive resistance training on insulin resistance and body composition in
older adults with type 2 diabetes and metabolic syndrome
Universal Trial Number (UTN)
Trial acronym
GREAT2DO: Graded Resistance Exercise And Type 2 diabetes in Older adults
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic syndrome and type 2 diabetes 1408 0
Condition category
Condition code
Metabolic and Endocrine 1503 1503 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For one year, experimental subjects will receive high intensity progressive resistance training of the major muscle groups 3 days per week using pneumatic resistance equipment, under supervision, in a community exercise facility. The exercises targeted include the majority of the large muscle groups: chest press, upper back, leg press, knee extension, hip extension, hip flexion and hip abduction. For each exercise, subjects will perform 3 sets of 8 repetitions with a fast concentric and slow eccentric phase on pneumatic resistance training machines (approximately 6 seconds per repetition, with 2 minutes of rest between sets), a regimen which has been shown to produce optimum adaptations in terms of fat, muscle, and lean mass, muscle power, strength, endurance, balance, depression, glucose homeostasis, and adiponectin increase in older adults. The intensity will be set at 80% of peak strength determined by the most recent 1 repetition maximum (1RM). Resistances used will be increased as tolerated using Borg scale rating of perceived exertion on a continuous basis throughout the 12 months, and 1RM testing will be repeated at 4-week intervals to ascertain progress and regulate intensity. Subjects will be followed for five years after the initial 12 months to track changes in lifestyle and clinical outcomes.
Intervention code [1] 1038 0
Treatment: Other
Comparator / control treatment
For one year, sham exercise subjects will be supervised by the same trainers in the same facility, but at different hours to avoid contamination and unblinding. These subjects will perform 2 sets of 8 repetitions for the same muscle groups, but with no loading beyond the bar of the machine, using 1-2 second concentric and eccentric contraction speed. No interim 1RM testing and no progression will take place. Subjects will be followed for five years after the initial 12 months to track changes in lifestyle and clinical outcomes.
Control group
Active

Outcomes
Primary outcome [1] 2074 0
Change in blood glucose control as measured via Glycosylated haemoglobin (HbA1c), collected from venous blood sample.
Timepoint [1] 2074 0
At baseline, 6 and 12 months
Primary outcome [2] 2075 0
Glucose Homeostasis using HOMA2 computer model for insulin sensitivity (IR, %S) and beta cell function (%Beta)
Timepoint [2] 2075 0
At baseline, 6 and 12 months
Secondary outcome [1] 3583 0
Cardiovascular Health: Resting heart rate variability, 24 hour ambulatory, post-prandial, and postural Blood Pressure, Ankle/Arm Blood Pressure Index.
Timepoint [1] 3583 0
Baseline, 6 and 12 months.
Secondary outcome [2] 3584 0
Lipid Metabolism: Basal fat oxidation via indirect calorimetry, intramuscular lipid content, total, low density, high density cholesterol, triglycerides, lipoprotein lipase.
Timepoint [2] 3584 0
Baseline, 6 and 12 months.
Secondary outcome [3] 3585 0
Muscle Metabolism: AMP-activated protein kinase, GLUT-4 receptor protein, intramuscular Insulin Growth Factor 1 (IGF-1), glycogen content, Adiponectin 1 Receptor protein in vastus lateralis muscle biopsies.
Timepoint [3] 3585 0
Baseline, 6 and 12 months.
Secondary outcome [4] 3586 0
Adipokines, Inflammatory Markers: Adiponectin, Tumor Necrosis Factor (TNF-), Interleukin 6 (IL-6), Interleukin 8 (IL-8), Interleukin 10 (IL-10) , C-reactive protein (CRP), leptin, resistin, in serum and adipose tissue biopsies.
Timepoint [4] 3586 0
Baseline, 6 and 12 months.
Secondary outcome [5] 3587 0
Body Composition: Bioelectrical impedance assessment of fat and fat free mass, muscle fibre cross-sectional areas, fibre typing and intramuscular lipid, waist circumference, body mass index (BMI).
Timepoint [5] 3587 0
Baseline, 6 and 12 months.
Secondary outcome [6] 3588 0
Exercise Capacity and Functional Status: VO2 peak (maximal treadmill test with indirect calorimetry, muscle strength (1RM test), power, endurance, habitual and maximal gait speed, static and dynamic balance, and stair climb power.
Timepoint [6] 3588 0
Baseline, 6 and 12 months.
Secondary outcome [7] 3589 0
Neuropsychological Profile: Geriatric depression scale, Pittsburgh Sleep Quality Index and Maislin Sleep Apnoea Scale, Ewart's Self-efficacy Scale, Trail Making Executive Function testing, Actigraph sleep architecture over 7 days.
Timepoint [7] 3589 0
Baseline, 6 and 12 months.
Secondary outcome [8] 3590 0
Health-Related Quality of Life: Medical Outcomes Survey SF-36 questionnaire.
Timepoint [8] 3590 0
Baseline, 6 and 12 months.
Secondary outcome [9] 3591 0
Nutritional Intake: Food frequency questionnaire of Block over past month.
Timepoint [9] 3591 0
Baseline, 6 and 12 months.
Secondary outcome [10] 3592 0
Energy Expenditure: Resting metabolic rate via indirect calorimetry, habitual physical activity and sedentary behaviour via Physical Activity Scale for the Elderly and Actigraph accelerometers over 7 days.
Timepoint [10] 3592 0
Baseline, 6 and 12 months.
Secondary outcome [11] 257274 0
Fasting plasma glucose concentration, collected from venous blood samples
Timepoint [11] 257274 0
Baseline, 6 and 12 months.
Secondary outcome [12] 257275 0
Diabetic medication inventory and dosages, determined via clinician interview and review of patient medical report obtained from their General Practitioner.
Timepoint [12] 257275 0
Baseline, 6 and 12 months.
Secondary outcome [13] 257276 0
Fat and muscle areas and muscle density measured via abdominal and thigh Computed Tomography (CT) scans.
Timepoint [13] 257276 0
Baseline, 6 and 12 months.
Secondary outcome [14] 257277 0
Insulin and C-peptide concentrations, from venous blood samples collected in a fasted state
Timepoint [14] 257277 0
Baseline, 6 and 12 months.
Secondary outcome [15] 257278 0
Pulse Wave Velocity (carotid/femoral method) and Augmentation Index (radial waveform) collected using applanation tonometry on a SphygmoCor PVx system
Timepoint [15] 257278 0
Baseline, 6 and 12 months.

Eligibility
Key inclusion criteria
Community dwelling men and women previously diagnosed with type 2 diabetes and meeting the current definition of metabolic syndrome according to the International Diabetes Federation. Subjects may be treated with diet alone, insulin or oral medications, or a combination of these treatments at the time of enrolment.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any change in type or dosage of diabetic medication in past 3 months, current fasting glucose > 11.1mmol/l,significant cognitive impairment, non-ambulatory status or lower extremity amputation other than toes, alcohol or substance abuse or specific contraindications to resistance training such as unstable cardiovascular disease, aortic aneurysm, symptomatic hernias, proliferative diabetic retinopathy, uncontrolled hypertension or rapidlyprogressive terminal illness.

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)
Sealed opaque envelopes will be prepared by a research assistant not otherwise involved in any aspect of this trial, containing sequential treatment assignments
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is at the level of the individual patient, and will be stratified by gender and use or non-use of insulin. The random order generation was based on a computer-generated randomisation scheme (by using the Web site Randomization.com set up by Dr Gerard E. Dallal).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The site trainer is blind to all assessment outcomes, the outcome assessor is blind to group assignment, the data analysers are blind to group assignment. CTs are de-identified prior to analysis.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/08/2006
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)

Funding & Sponsors
Funding source category [1] 1638 0
Charities/Societies/Foundations
Name [1] 1638 0
Diabetes Australia
Country [1] 1638 0
Australia
Funding source category [2] 1639 0
University
Name [2] 1639 0
University of Sydney
Country [2] 1639 0
Australia
Funding source category [3] 237523 0
Government body
Name [3] 237523 0
NHMRC - Project Grant
Country [3] 237523 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Diabetes Australia
Address
GPO BOX 3156
CANBERRA ACT 2601
Country
Australia
Secondary sponsor category [1] 1445 0
None
Name [1] 1445 0
NIL
Address [1] 1445 0
Country [1] 1445 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3083 0
University of Sydney - Human Research Ethics Committee, The University of Sydney
Ethics committee address [1] 3083 0
Ethics committee country [1] 3083 0
Australia
Date submitted for ethics approval [1] 3083 0
Approval date [1] 3083 0
04/08/2006
Ethics approval number [1] 3083 0
X04-0096
Ethics committee name [2] 3084 0
Freshwater Health and FitnessHarbord Diggers Memorial Club -Human Research Ethics Committee, The University of Sydney
Ethics committee address [2] 3084 0
Ethics committee country [2] 3084 0
Australia
Date submitted for ethics approval [2] 3084 0
Approval date [2] 3084 0
04/08/2006
Ethics approval number [2] 3084 0
X04-0096
Ethics committee name [3] 3085 0
Royal Prince Alfred Hospital-South Sydney West Area Health Service
Ethics committee address [3] 3085 0
Ethics committee country [3] 3085 0
Australia
Date submitted for ethics approval [3] 3085 0
Approval date [3] 3085 0
02/08/2006
Ethics approval number [3] 3085 0
X04-0096

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35221 0
Address 35221 0
Country 35221 0
Phone 35221 0
Fax 35221 0
Email 35221 0
Contact person for public queries
Name 10227 0
Professor Maria Fiatarone Singh
Address 10227 0
University of Sydney
Faculty of Health Sciences
East Street
Lidcombe NSW 2141
Country 10227 0
Australia
Phone 10227 0
+61 2 93519755
Fax 10227 0
+61 2 93519204
Email 10227 0
[email protected]
Contact person for scientific queries
Name 1155 0
Professor Maria Fiatarone Singh
Address 1155 0
University of Sydney
Faculty of Health Sciences
East Street
Lidcombe NSW 2141
Country 1155 0
Australia
Phone 1155 0
+61 2 93519755
Fax 1155 0
+61 2 93519204
Email 1155 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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