Trial from ANZCTR


Trial ID ACTRN12609001085268
Trial Status: Registered
Date Submitted: 19/11/2007
Date Registered: 18/12/2009
Retrospectively registered

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Public title South Pacific Islands Resist diabetes with Intense Training: A randomised trial
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format The SPIRIT Study: South Pacific Islands Resist diabetes with Intense Training: A randomised trial
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Secondary ID [1] 1213 0
None
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UTN
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Trial acronym SPIRIT Study
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Health condition(s) or problem(s) studied:
obesity 2551 0
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type 2 diabetes 2552 0
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Condition category: Condition code:
Metabolic and Endocrine Diabetes
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2652 2652 0 0
Public Health Health promotion/education
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252418 252418 0 0

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Descriptions of intervention(s) / exposure 16 weeks of progressive resistance training (weight lifting), three times per week, 45 min per session on eight machine-based resistance exercises in a circuit format: seated leg press, knee extension, knee flexion, chest press, lat pulldowns, overhead press, biceps curls, triceps extension (Cybex International, Medway, MA). Initial weights starting weights determined as a percentage of the extrapolated 1-repetition maximum (1RM) as previously described by Brzycki et al (1993). Thereafter using a graduated periodized regimen where subjects progress from 65% to 85% of their extrapolated 1RM over the course of phase 1, two sets at 85% during phase 2, three sets at 85% during phase 3, and a continuation of three sets at 85% until conclusion of the intervention. Perform 6 to 8 repetitions with a 1 minute rest between sets. Workloads increased by 5% when subjects can perform 10 repetitions. Onsite exercise leaders supervised by lead clinical exercise physiologist encourage exercise at a a perceived exertion of “hard,” or 15, on the Borg scale.
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Intervention Code:
Lifestyle 2283 0
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Comparator / control treatment 16 weeks of aerobic training: 3 times per week, 45 min per session, performing a graduated progressive cycle ergometry (Life Fitness, Schiller Park, IL) protocol in parallel with the resistance training group. Gradual progression of 5 to 10% workload to minimise delayed onset muscle soreness. Subjects progressed from 65 to 85% of their heart rate reserve and encouraged to sustain a perceived exertion of “hard” on the Borg scale. Heart rate and blood pressure monitored and recorded at peak steady state workloads. Workloads (watts) and duration at peak intensity increased to accommodate subjects’ improved fitness levels. Direct supervision by exercise leaders and lead clinical exercise physiologist.
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Control group Active
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Primary Outcome: glycaemic control (haemoglobin A1c): Determined by ion exchange high pressure liquid chromatography using the Bio-Rad D-10 analyzer (Bio-Rad Laboratories, Hercules, CA) with a coefficient of variation (CV) of 3%. 3562 0
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Timepoint: baseline and 16 weeks 3562 0
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Secondary Outcome: Insulin resistance: Determined from fasting glucose and insulin using the most recent HOMA2-IR calculator (version 2.2.2, Oxford University). 5962 0
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Timepoint: baseline and 16 weeks 5962 0
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Secondary Outcome: Blood lipids (Total Cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides (TG) were determined via standard enzymatic methods (Roche/Hitachi lipid assay kits) with a Roche Modular Analyzer with a CV of 3% on each assay. LDL mathematically determined as total cholesterol minus HDL minus (0.45 x TG). 5979 0
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Timepoint: baseline and 16 weeks 5979 0
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Secondary Outcome: C-Reactive Protein: Determined by latex agglutination method on the Roche Modular Analyzer with a CV of 4%. 5980 0
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Timepoint: baseline and 16 weeks 5980 0
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Secondary Outcome: Adiponectin: Determined by radioimmunoassay (Linco Research, St. Charles, MO, USA) with a CV of 8.8%. 5981 0
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Timepoint: baseline and 16 weeks 5981 0
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Secondary Outcome: Anthropometric indices (Height, weight, Body Mass Index (BMI), waist and hip circumference, waist/hip ratio:

Height and weight measured to the nearest 0.1cm and 0.1kg on a standard hospital-grade stadiometer and scale, respectively. BMI calculated from standard formula: kg/m2. Waist circumference was measured to the nearest 0.1cm at the end of normal expiration and the midpoint between the lower costal margin and the iliac crest using, and hip circumference taken with feet together at the widest protuberance of the buttocks, using a retractable steel tape measure (model F10-02. KDS Corporation, Japan).
5982 0
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Timepoint: baseline and 16 weeks 5982 0
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Secondary Outcome: Body composition: Lean body mass (LBM), fat mass (FM), and percent body fat (%BF) estimated via bioelectrical impedance analysis (BIA) on a Tanita TBF-310 analyzer (Tanita Corporation, Arlington Heights, Illinois, USA). 5983 0
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Timepoint: baseline and 16 weeks 5983 0
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Secondary Outcome: haemodynamics (Heart rate (HR) and Blood Pressure (BP)): Seated blood pressure was measured in duplicate on the left arm after 5 minutes rest on a standard hospital-grade sphygmomanometer. Heart rate measured by counting radial pulse for a full 60 seconds. Exercise pulse determined manually on all subjects, but corroborated by use of pulse monitor on aerobic equipment. 5984 0
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Timepoint: baseline and 16 weeks 5984 0
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Secondary Outcome: Dynamic upper and lower body strength: Due to level of obesity and deconditioning in this population and because strength was only determined as a means to identify starting weights, a 1-Repetition Max (1-RM) was deemed unnecessary. Instead a 10RM as determined by the protocol set forth by Brzycki (1993) was more appropriate to minimise delayed onset muscle soreness and possibly minimise early dropout. 5985 0
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Timepoint: baseline and 16 weeks 5985 0
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Secondary Outcome: Quality of Life Short-Form 36(SF-36) questionnaire.

The SF36 quality of life questionnaire is comprised of 36 questions which encompass 8 different areas of physical and mental health and is useful for comparing the burden of different diseases, differentiating the health benefits produced by different treatments, and in screening individual patients.
5986 0
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Timepoint: baseline and 16 weeks 5986 0
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Secondary Outcome: Activity Levels (International Physical Activity Questionnaire) 5987 0
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Timepoint: baseline and 16 weeks 5987 0
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Secondary Outcome: muscle markers (muscle fibre type and cross-sectional area, mitochondrial density, intramuscular triglyceride, capillary density, GLUT4). Method: standard biopsy of vastus lateralis by highly trained/experienced doctor, snap frozen samples, later sectioned, mounted, and results determined by immunohistochemical methods and electron microscopy. Digital images captured analzyed on software to quantify indicated parameters. 5988 0
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Timepoint: baseline and 16 weeks 5988 0
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Key inclusion criteria Self-identified Polynesian descent (Maori, Pacific Islands people).
Diagnosed type 2 diabetes.
Central obesity as defined by a waist girth of 88cm in women and 102cm in men.
No change in diabetes medications for previous two months.
No documented cardiac history or stable cardiac history for previous 6 months.
Not currently taking exogenous insulin injections.
Must be stable and medically managed.
Signed consent from their general practitioner (GP) or specialist.
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Minimum age 18 Years
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Maximum age 60 Years
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria Diabetic complications which may be worsened by weight lifting exercise.
Change in meds during previous 2 months.
Unstable cardiovascular disease, stroke, or other conditions which might be worsened by weight lifting exercise.
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Concealed opaque envelope. Assignment following baseline testing.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Computer-generated randomization list.
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase
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Anticipated date of first participant enrolment 1/02/2008
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 40
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Recruitment status Completed
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

Country: New Zealand 657 0
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State/Province: 657 0
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Funding Source: University 2795 0
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Name: Massey University 2795 0
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Address: PO Box 756
Wellington
2795 0
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Country: New Zealand 2795 0
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Primary Sponsor University
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Name: Massey University
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Address: PO Box 756
Wellington
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Country: New Zealand
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Secondary Sponsor: None 2526 0
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Name: 2526 0
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Address: 2526 0
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Country: 2526 0
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Other Collaborator: Hospital 90 0
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Name: Capital and Coast District Health Board 90 0
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Address: Level 1/36 Tacy Street
Kilbirnie 6022, Wellington
(04) 387 1270
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Country: New Zealand 90 0
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Other Collaborator: Charities/Societies/Foundations 91 0
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Name: National Heart Foundation 91 0
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Address: 28 The Terrace
PO Box 5357
Lambton Quay
Wellington
phone (04) 472 2780
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Country: New Zealand 91 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Central Regional Ethics Committee 258140 0
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Address: Central Regional Ethics Committee
Ministry of Health
Level 2, 1-3 The Terrace
PO Box 5013
Wellington
258140 0
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Country: New Zealand 258140 0
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Approval Date: 16/10/2007 258140 0
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Submitted Date: 258140 0
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HREC: CEN/07/08/054 258140 0
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Brief summary A small number of multidisciplinary lifestyle interventions for diabetes prevention and weight reduction have been conducted in obese Polynesian (Maori and Pacific Islands people) populations but to date none were designed to isolate the specific impact of the exercise component. To our knowledge, no structured exercise trials have been conducted in obese Maori and Pacific Islands people with type 2 diabetes. Therefore, the purpose of this study was two-fold: (1) to evaluate whether high intensity resistance training (weight lifting) or aerobic exercise can improve glycemic control and associated cardiometabolic aberrations in sedentary Polynesian people with morbid obesity and diagnosed type 2 diabetes; and (2) to determine which type of exercise is more effective for improving glycemic control given an equivalent training intensity and duration. Because resistance training has been shown to improve overall muscle strength and metabolism, we hypothesised that this form of exercise would result in greater reductions in glycated haemoglobin
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Trial website
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: William R. Sukala,MSc
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Address: Massey University IFNHH PO Box 756 Wellington
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Country: New Zealand
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Tel: +64 - 4 - 801 5799 ext 62290
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Email: w.r.sukala@massey.ac.nz
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Contact person for scientific queries
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Name: William R. Sukala,MSc
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Address: Massey University IFNHH PO Box 756 Wellington
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Contact person responsible for updating information
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Name: William R. Sukala,MSc
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Address: Massey University IFNHH PO Box 756 Wellington
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Addition Cancer fields
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