Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000640707
Ethics application status
Approved
Date submitted
13/04/2022
Date registered
2/05/2022
Date last updated
2/05/2022
Date data sharing statement initially provided
2/05/2022
Date results provided
2/05/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Long-Term Effects of Resistance Training and Diet in Elderly Type 2 Diabetics
Scientific title
The Long-Term Effects of Resistance Training and Diet in Elderly Type 2 Diabetics
Secondary ID [1] 306922 0
Nil known
Universal Trial Number (UTN)
Trial acronym
LLL study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 326028 0
Condition category
Condition code
Musculoskeletal 323333 323333 0 0
Other muscular and skeletal disorders
Metabolic and Endocrine 323334 323334 0 0
Diabetes
Diet and Nutrition 323335 323335 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a two-arm, 12-month RCT which will consist of two phases involving older overweight and obese adults with type 2 diabetes. Specifically, the program is designed to investigate whether 6 months of high intensity progressive resistance training (PRT) within a supervised and structured setting combined with weight loss (WL) can reduce HbA1C, increase muscle strength and lean body mass and decrease fat mass in older overweight and obese adults with T2D compared to weight loss alone

Following baseline assessments, participants will be randomised (1:1) ratio to receive either PRT + WL or sham (flexibility) training + WL. An accredited Exercise Physiologist will prescribe and supervise the initial exercise program. Those participants allocated to PRT + WL for the first six-months will attend the exercise laboratory at Deakin University three non-consecutive days per week and perform an individually prescribed 45-60 minutes, high intensity (75-85% of their one repetition maximum strength) program consisting of free weights and weights machines (three sets of 8-10 repetitions, nine exercises). Following the 6-month supervised gym-based intervention, participants will be prescribed a home-based exercise program in which they will be provided with individual instructions and equipment (dumbbells and ankle weights). Participants will be asked to train three days per week at home and/or at a community or commercial leisure centre. To facilitate transition to the home-based intervention, participants in the PRT + WL group will perform the home-based PRT program within the structured and supervised gym setting for the final month of phase 1. The home-based exercises (duration: 45-60 minutes) will replace weights machines with dumbbells and ankle weights and participants will be requested to complete nine exercises (three sets of 8-10 repetitions) with aim to exercise at a moderate intensity (at least 60% of maximum). Participants will attend the gymnasium once per month to monitor technique and progression and complete weekly exercise diaries to monitor adherence. In addition, weekly phone calls (first month) and subsequent fortnightly calls will monitor adherence and enable participant questions and feedback. Home visits will be conducted in week one to ensure safety and provide additional weights to facilitate progression.

All participants will also be placed on a healthy eating plan supplying less than or equal to 30% total energy from total fat (less than or equal to 10% saturated fat) with protein and carbohydrate being distributed for remaining energy. Individually prescribed by a dietitian, the healthy eating plan is designed to induce moderate weight loss (~0.25 kg per week) throughout phase 1. Interviews every two weeks by the dietitian and completion of a weekly checklist will be used to assess adherence. Changes in nutrient intake will be assessed via a 3-day food record conducted at 3 and 6 months. Nutrition information will be analysed using Foodworks nutrient analysis software (Xyris, Brisbane, Queensland, Australia). Following the first 6-month gym-based intervention, participants will not be required to adhere to the healthy eating (WL) plan and will not receive further dietary recommendations.
Intervention code [1] 323369 0
Treatment: Other
Intervention code [2] 323370 0
Lifestyle
Comparator / control treatment
The sham (flexibility) + WL group will attend the exercise laboratory at Deakin University three non-consecutive days per week and perform sessions consisting of five minutes of stationary cycling (no workload) followed by a sequence of static stretching exercises (~30 minutes) designed to provide participation and improve flexibility but not to elicit changes in muscle strength or fitness). Following the first 6-months, participants in the control flexibility group will be requested to maintain the flexibility program at home.

Participants in the control group will also be placed on a healthy eating plan supplying less than or equal to 30% total energy from total fat (less than or equal to 10% saturated fat) with protein and carbohydrate being distributed for remaining energy. Individually prescribed by a dietitian, the healthy eating plan is designed to induce moderate weight loss (~0.25 kg per week) throughout phase 1. Interviews every two weeks by the dietitian and completion of a weekly checklist will be used to assess adherence. Changes in nutrient intake will be assessed via a 3-day food record conducted at 3 and 6 months. Nutrition information will be analysed using Foodworks nutrient analysis software (Xyris, Brisbane, Queensland, Australia). Following the first 6-month, participants will not be required to adhere to the healthy eating (WL) plan and will not receive further dietary recommendations.
Control group
Active

Outcomes
Primary outcome [1] 331068 0
HbA1C measured by blood samples
Timepoint [1] 331068 0
Timepoint: baseline, then 3, 6, 9 and 12 months (primary timepoint) after randomisation
Primary outcome [2] 331069 0
Insulin sensitivity HOMA (%) measured by blood samples
Timepoint [2] 331069 0
Timepoint: baseline, then 3, 6, 9 and 12 months (primary timepoint) after randomisation
Primary outcome [3] 331070 0
Fasting plasma glucose measured by blood samples
Timepoint [3] 331070 0
Timepoint: baseline, then 3, 6, 9 and 12 months (primary timepoint) after randomisation
Secondary outcome [1] 408622 0
Fasting serum insulin measured by blood samples
Timepoint [1] 408622 0
Timepoint: baseline, then 3, 6, 9 and 12 months after randomisation
Secondary outcome [2] 408623 0
Total cholesterol measured by blood samples
Timepoint [2] 408623 0
Timepoint: baseline, then 3, 6, 9 and 12 months after randomisation
Secondary outcome [3] 408624 0
HDL cholesterol measured by blood samples
Timepoint [3] 408624 0
Timepoint: baseline, then 3, 6, 9 and 12 months after randomisation
Secondary outcome [4] 408625 0
Triglycerides measured by blood samples
Timepoint [4] 408625 0
Timepoint: baseline, then 3, 6, 9 and 12 months after randomisation
Secondary outcome [5] 408626 0
Fat mass (kg) measured via dual energy X-ray absorptiometry (DXA)
Timepoint [5] 408626 0
Timepoint: baseline, then 6 and 12 months after randomisation
Secondary outcome [6] 408627 0
Lean body mass (kg) measured via dual energy X-ray absorptiometry (DXA)
Timepoint [6] 408627 0
Timepoint: baseline, then 6 and 12 months after randomisation
Secondary outcome [7] 408628 0
Percentage body fat measured via dual energy X-ray absorptiometry (DXA)
Timepoint [7] 408628 0
Timepoint: baseline, then 6 and 12 months after randomisation
Secondary outcome [8] 408629 0
Muscle strength upper body (% change) measured via 1RM testing
Timepoint [8] 408629 0
Timepoint: baseline, then 3, 6, 9 and 12 months after randomisation
Secondary outcome [9] 408630 0
Muscle strength lower body (% change) measured via 1RM testing
Timepoint [9] 408630 0
Timepoint: baseline, then 3, 6, 9 and 12 months after randomisation
Secondary outcome [10] 408631 0
Systolic blood pressure (mmHg) measured via blood pressure monitor
Timepoint [10] 408631 0
Timepoint: baseline, then 3, 6, 9 and 12 months after randomisation
Secondary outcome [11] 408632 0
Diastolic blood pressure (mmHg) measured via blood pressure monitor
Timepoint [11] 408632 0
Timepoint: baseline, then 3, 6, 9 and 12 months after randomisation
Secondary outcome [12] 408633 0
Energy expenditure (kcal/day) measured via 7-day physical activity recall
Timepoint [12] 408633 0
Timepoint: baseline, then 3, 6, 9 and 12 months after randomisation
Secondary outcome [13] 408634 0
Total energy intake (kcal/day) measured via 3-day food record
Timepoint [13] 408634 0
Timepoint: baseline, then 3, 6, 9 and 12 months after randomisation
Secondary outcome [14] 408635 0
Femoral neck bone mineral density measured via dual energy X-ray absorptiometry (DXA)
Timepoint [14] 408635 0
Timepoint: baseline, then 6 and 12 months after randomisation
Secondary outcome [15] 408636 0
Lumbar spine bone mineral density measured via dual energy X-ray absorptiometry (DXA)
Timepoint [15] 408636 0
Timepoint: baseline, then 6 and 12 months after randomisation
Secondary outcome [16] 408637 0
Bone mineral content measured via dual energy X-ray absorptiometry (DXA)
Timepoint [16] 408637 0
Timepoint: baseline, then 6 and 12 months after randomisation
Secondary outcome [17] 408638 0
Total body bone mineral density measured via dual energy X-ray absorptiometry (DXA)
Timepoint [17] 408638 0
Timepoint: baseline, then 6 and 12 months after randomisation
Secondary outcome [18] 408639 0
Inflammatory marker interleukin (IL-10 and IL-6) measured by blood samples
Timepoint [18] 408639 0
Timepoint: baseline, then 3, 6, 9 and 12 months after randomisation
Secondary outcome [19] 408640 0
Inflammatory marker tumor necrosis factor measured by blood samples
Timepoint [19] 408640 0
Timepoint: baseline, then 3, 6, 9 and 12 months after randomisation
Secondary outcome [20] 408641 0
Inflammatory marker adiponectin measured by blood samples
Timepoint [20] 408641 0
Timepoint: baseline, then 3, 6, 9 and 12 months after randomisation
Secondary outcome [21] 408642 0
Endothelial marker resistin marker adiponectin measured by blood samples
Timepoint [21] 408642 0
Timepoint: baseline, then 3, 6, 9 and 12 months after randomisation
Secondary outcome [22] 408643 0
Endothelial marker intercellular adhesion molecule marker adiponectin measured by blood samples
Timepoint [22] 408643 0
Timepoint: baseline, then 3, 6, 9 and 12 months after randomisation
Secondary outcome [23] 408644 0
Fatty liver index measured by blood samples
Timepoint [23] 408644 0
Timepoint: baseline, then 3, 6, 9 and 12 months after randomisation

Eligibility
Key inclusion criteria
Participants must have established T2D (greater than 6 months), being treated with diet or oral hypoglycaemic agent (excluding insulin), HbA1c range 7-10%, overweight or obese (BMI greater than 27 kg/m2 and less than or equal to 40 kg/m2), not participating in regular PRT and engaging in less than 150 minutes moderate or less than 60 minutes vigorous exercise/week (preceding 6 months), non-smoker and consuming less than 2 alcoholic drinks/day.
Minimum age
60 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if history/evidence of ischemic heart disease, systemic diseases, hypertension (>160/90mmHg), advanced diabetic neuropathy and/or retinopathy and conditions (severe orthopaedic, cardiovascular or respiratory) that prevent participation and those with absolute exercise contraindications (American College of Sports Medicine).

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)
Participants will be randomly assigned to either of the two groups by an independent researcher not directly involved in the study to conceal allocation. Research staff conducting all assessments and the statistical analysis will be blinded to the group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation via a computer-generated random number table in Excel, stratified by gender, with a 1:1 allocation to the PRT + WL and Sham + WL group.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A total of 75 participants will be recruited, allowing for a 20% attrition rate as per the power calculations for this study. Data analysis will include independent t tests to assess between group comparisons at baseline. Net differences at 3, 6, 9 and 12 months will be calculated by subtracting the within group changes from baseline for the Sham + WL group from the within group changes for the PRT + WL group. Time, group, and interaction effects will be examined using a two=way ANOVA or ANCOVA with repeated measures on one factor (time). Descriptive variables will be calculated using SPSS software and reported as mean (SD).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/06/1999
Date of last participant enrolment
Anticipated
Actual
28/01/2000
Date of last data collection
Anticipated
Actual
31/01/2001
Sample size
Target
75
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 311242 0
Government body
Name [1] 311242 0
Victorian Health Promotion Foundation
Country [1] 311242 0
Australia
Primary sponsor type
Other
Name
Baker Heart and Diabetes Institute
Address
99 Commercial Rd Melbourne, 3004 VIC
Country
Australia
Secondary sponsor category [1] 312600 0
University
Name [1] 312600 0
Deakin University
Address [1] 312600 0
221 Burwood Hwy Burwood, VIC 3125
Country [1] 312600 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310768 0
International Diabetes Institute Human Research Ethics Committee
Ethics committee address [1] 310768 0
Ethics committee country [1] 310768 0
Australia
Date submitted for ethics approval [1] 310768 0
Approval date [1] 310768 0
29/01/1999
Ethics approval number [1] 310768 0
2/98

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

Contacts
Principal investigator
Name 118754 0
Prof David Dunstan
Address 118754 0
Baker Heart and Diabetes Institute
75 Commercial Road
Melbourne, VIC 3004
Country 118754 0
Australia
Phone 118754 0
+61 385321873
Fax 118754 0
Email 118754 0
[email protected]
Contact person for public queries
Name 118755 0
David Dunstan
Address 118755 0
Baker Heart and Diabetes Institute
75 Commercial Road
Melbourne, VIC 3004
Country 118755 0
Australia
Phone 118755 0
+61 385321873
Fax 118755 0
Email 118755 0
[email protected]
Contact person for scientific queries
Name 118756 0
David Dunstan
Address 118756 0
Baker Heart and Diabetes Institute
75 Commercial Road
Melbourne, VIC 3004
Country 118756 0
Australia
Phone 118756 0
+61 385321873
Fax 118756 0
Email 118756 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Study is now closed


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
SourceTitleYear of PublicationDOI
EmbaseEffect of progressive resistance training with weight loss compared with weight loss alone on the fatty liver index in older adults with type 2 diabetes: secondary analysis of a 12-month randomized controlled trial.2022https://dx.doi.org/10.1136/bmjdrc-2022-002950
N.B. These documents automatically identified may not have been verified by the study sponsor.