Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000340730
Ethics application status
Not yet submitted
Date submitted
20/03/2013
Date registered
27/03/2013
Date last updated
27/03/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Can Amino Acids in Combination with Exercise Training Improve Metabolic Flexibility and Cardiovascular Health in Type-2 Diabetics?
Scientific title
Can Combined Amino Acid And Exercise Therapy For Type-2 Diabetes Improve Cardiovascular Health and Metabolic Flexibility?
Secondary ID [1] 282162 0
The trial has no secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-insulin dependent type-2 diabetes 288533 0
Condition category
Condition code
Metabolic and Endocrine 288867 288867 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the AA + EX group will underake a 10-week weekday morning small-group mixed-mode exercise program and consume a pre- and post-exercise supplement. All sessions willl be supervised by exercise physiologists. The exercise program entails 3 days of 20 minutes of interval cycling on an ergometer for 20 minutes at 30% and 60% of maximal work capacity, and 2 days of 30 minutes of upper-body resistance circuit training at 60% of 1 repitition maximum plus core exercises (plus warm up and cool down exercises). Maximal cycling work capacity and maximum strength on resistance exercises will be reassesed fortnightly and workloads adjusted to maintain prescribed intensities. The treatment is a 200ml pre-packaged drink containing 15g whey protein, 3g leucine, 15g carbohydrate, and 5g of fat. Drinks will be consumed immediately before and after exercise and at the same time by participants in the supplement only group.
Intervention code [1] 286648 0
Rehabilitation
Intervention code [2] 286649 0
Treatment: Other
Intervention code [3] 286767 0
Lifestyle
Comparator / control treatment
1. Participants randomised to the AA group will not attend exercise sessions but will consume the leucine-enriched milk-protein drink at the same time as participants in the exercise groups for 10 weeks.
2. Participants randomised to the EX group will attend exercise sessions for 10 weeks and consume a pre- and post-exercise isocaloric placebo of similar taste containing 33g of carbohydrate and 5g of fat.
Control group
Active

Outcomes
Primary outcome [1] 288993 0
Whole-body glucose disposal rate during hyperinsulinemic euglycaemic clamp
Timepoint [1] 288993 0
At baseline and after 10 weeks
Primary outcome [2] 288994 0
Flow mediated dilation of the brachial artery by ultrasound
Timepoint [2] 288994 0
At baseline and after 10 weeks
Secondary outcome [1] 301517 0
Arterial stiffness at the brachial artery by pulse wave analysis
Timepoint [1] 301517 0
At baseline and after 10 weeks
Secondary outcome [2] 301518 0
HOMA from fasting plasma glucose and insulin concentration
Timepoint [2] 301518 0
At baseline and after 10 weeks
Secondary outcome [3] 301519 0
Mitochondrial capacity at the Vastus Lateralis muscle by near-infrared spectroscopy (NIRS)
Timepoint [3] 301519 0
At baseline and after 10 weeks
Secondary outcome [4] 301520 0
Microvascular blood flow at the Vastus Lateralis muscle by NIRS
Timepoint [4] 301520 0
At baseline and after 10 weeks
Secondary outcome [5] 301521 0
Metabolic flexibility by respiratory exchange ratio during breath by breath gas analysis
Timepoint [5] 301521 0
Baseline: before and during clamp; before and during exercise
Repeated after 10 weeks
Secondary outcome [6] 301522 0
Skeletal muscle capillary density via immunocytochemistry
Timepoint [6] 301522 0
At baseline and after 10 weeks
Secondary outcome [7] 301523 0
Insulin stimulated skeletal muscle capillary recruitment at the Vastus Lateralis via NIRS
Timepoint [7] 301523 0
At baseline: before and during clamp
Repeated after 10 weeks
Secondary outcome [8] 301524 0
Skeletal muscle tissue fibrosis via endomysium cross-sectional area (immunocytochemistry) and hydroxyproline concentration (ELISA assay)
Timepoint [8] 301524 0
At baseline and after 10 weeks
Secondary outcome [9] 301525 0
Skeletal muscle mitochondrial function 1) density via electron microscopic densitometry 2) mitochondrial enzyme activity (citrate synthase, cytochrome c oxidase and 5 subunits, beta-hydroxyacyl-CoA-dehydrogenase via immunoblot
Timepoint [9] 301525 0
At baseline and after 10 weeks
Secondary outcome [10] 301527 0
Total and sarcolemmal glucose transporter 4 content via immunoblot
Timepoint [10] 301527 0
At baseline: before and during clamp
Repeated after 10 weeks
Secondary outcome [11] 301528 0
Intramyocellular lipid content via electron microscopy densitometry
Timepoint [11] 301528 0
At baseline and after 10 weeks
Secondary outcome [12] 301529 0
Insulin stimulated GLUT4 translocation associated signaling protein activity via immunoblot of phosphorylated IRS, PI3K, AS160, and akt, in Vastus Lateralis muscle
Timepoint [12] 301529 0
At baseline: before and during clamp
Repeated after 10 weeks
Secondary outcome [13] 301530 0
Skeletal muscle growth via immunocytochemistry of myocellular volume and bioelectrical impedance of total lean body mass
Timepoint [13] 301530 0
At baseline and after 10 weeks
Secondary outcome [14] 301531 0
Aerobic capacity via breath by breath gas analysis during an incremental maximal cycle ergometer test
Timepoint [14] 301531 0
At baseline and after 10 weeks
Secondary outcome [15] 301532 0
Maximal strength via 1 repetition max test on leg press and smith machine bench press
Timepoint [15] 301532 0
At baseline and after 10 weeks
Secondary outcome [16] 301533 0
Plasma concentration of cholesterol, triglycerides, and high-density lipoproteins
Timepoint [16] 301533 0
At baseline and after week 10
Secondary outcome [17] 301534 0
Whole-body fat mass via bioelectrical impedence
Timepoint [17] 301534 0
At baseline and after 10 weeks
Secondary outcome [18] 301535 0
Concentration of myostatin and associated regulators (follistatin, FLRG, activin-receptor) in skeletal muscle via immunoblot
Timepoint [18] 301535 0
At baseline and after 10 weeks
Secondary outcome [19] 301536 0
Genetic adaptation to support other outcomes via gene array and epigenetic analysis
Timepoint [19] 301536 0
At baseline: before and after clamp
Repeated after 10 weeks
Secondary outcome [20] 301637 0
Functional health and well-being via psychometric assessment using SF36
Timepoint [20] 301637 0
At baseline and after 10 weeks

Eligibility
Key inclusion criteria
Non-insulin dependent Type-2 diabetics (T2DM)diagnosed for a minimum of 1 year, HbA1c between 7 and 9%, BMI 25-32, stable weight and non-participation in regular exercise in past 6 months.
Minimum age
40 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Use of beta-blockers, moderate to severe retinopathy, nephropathy and neuropathy, history of cerebrovascular or cardiovascular diseases, or evidence of other clinical contraindications preventing moderate to high-intensity exercise, including cardiac irregularities that may appear during baseline maximal aerobic testing.

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 recruited through advertising and through medical centres in Wellington NZ, based upon database records identifying them as meeting the eligibility criteria.
After baseline testing, a researcher not involved in the study will randomly allocate participants to treatment and control groups. The experiment is semi-blinded. Researchers involved in the study and participants will be blind to allocation of treatment and placebo to the exercise groups, but will not be blind to participants allocated to the AA (supplement-only) group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization sequence will be generated using the following internet source (http://www.randomizer.org/form.htm). The randomization sequence (i.e. AA = supplement only; EX = exercise only; AA+EX = supplement plus exercise) will be placed in a sequentially numbered envelope (from 1-36) based on the derived sequence generated by the website
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The between group effect of treatment will be analysed using mixed linear models via the Proc Mixed utility in SAS (SAS, Cary, NC). Fixed effects within the linear models with polynomial contrasts if warranted will be group (treatment) and time. Random effects (covariance matrix) will be subject, amino acid therapy; additional random effects may be added following evaluation of other sources of variability. The baseline values will be added as a covariate to adjust for between-subject variability. Parametric data will be log-transformed prior to analysis, which allows for changes to be expressed as percents and manages heterscedasity to meet the requirements normally-distributed data. Clinical inference and inference to mechanisms outcomes will be via the method of magnitude-based inference.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2013
Actual
Date of last participant enrolment
Anticipated
1/04/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment outside Australia
Country [1] 4895 0
New Zealand
State/province [1] 4895 0

Funding & Sponsors
Funding source category [1] 286830 0
University
Name [1] 286830 0
Masssey University
Country [1] 286830 0
New Zealand
Primary sponsor type
University
Name
Massey University Wellington
Address
63 Wallace St
Mt Cook, Wellington. 6021
Country
New Zealand
Secondary sponsor category [1] 285620 0
None
Name [1] 285620 0
Address [1] 285620 0
Country [1] 285620 0
Other collaborator category [1] 277312 0
Hospital
Name [1] 277312 0
Capital and Coast District Health Board
Endocrine, Diabetes and Research Centre
Address [1] 277312 0
Capital and Coast District Health Board
Endocrine, Diabetes and Research Centre
Level 5, Grace Neill Block, Wellington Regional Hospital.
Newtown, Wellington NZ. 6021
Country [1] 277312 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288895 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 288895 0
Ethics committee country [1] 288895 0
New Zealand
Date submitted for ethics approval [1] 288895 0
13/03/2013
Approval date [1] 288895 0
Ethics approval number [1] 288895 0

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

Contacts
Principal investigator
Name 37342 0
Mr Kim Gaffney
Address 37342 0
School of Sport and Exercise, College of Health, Massey University
63 Wallace St
Mt Cook, Wellington, 6021
Country 37342 0
New Zealand
Phone 37342 0
+64 4 8014994
Fax 37342 0
Email 37342 0
[email protected]
Contact person for public queries
Name 37343 0
Kim Gaffney
Address 37343 0
School of Sport and Exercise, College of Health, Massey University
63 Wallace St
Mt Cook, Wellington, 6021
Country 37343 0
New Zealand
Phone 37343 0
+64 4 8014994
Fax 37343 0
Email 37343 0
[email protected]
Contact person for scientific queries
Name 37344 0
Kim Gaffney
Address 37344 0
School of Sport and Exercise, College of Health, Massey University
63 Wallace St
Mt Cook, Wellington, 6021
Country 37344 0
New Zealand
Phone 37344 0
+64 4 8014994
Fax 37344 0
Email 37344 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
SourceTitleYear of PublicationDOI
Dimensions AIEffects of whey protein on skeletal muscle microvascular and mitochondrial plasticity following 10 weeks of exercise training in men with type 2 diabetes2021https://doi.org/10.1139/apnm-2020-0943
N.B. These documents automatically identified may not have been verified by the study sponsor.