Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000273785
Ethics application status
Not yet submitted
Date submitted
13/02/2013
Date registered
6/03/2013
Date last updated
6/03/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of beta-alanine supplementation on exercise capacity in people with type 2 diabetes
Scientific title
The effect of beta-alanine supplementation on exercise capacity in individuals with type 2 diabetes: a randomized double-blind, placebo-controlled trial
Secondary ID [1] 281952 0
Nil
Universal Trial Number (UTN)
U1111-1139-5111
Trial acronym
BASED Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 288369 0
Obesity 288370 0
Condition category
Condition code
Metabolic and Endocrine 288715 288715 0 0
Diabetes
Diet and Nutrition 288777 288777 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental subjects will receive 4g beta-alanine capsules (oral capsules) once daily for 28 days.

An incremental treadmill test supervised by a PhD-level accredited exercise physiologist will be carried out at baseline and at 28 days (4 weeks). We will employ a ramp protocol (ACSM Guidelines for Exercise Testing and Prescription, 8th edition, pg 114) for which we are assessing exercise endurance. The test will be terminated when the participant has reached at least 85% age-predicted max heart rate or s/he requests to stop. We will also use an ECG to assess for any potential abnormal cardiac responses (i.e., ST segment depression, ventricular arrythmias, etc as per ACSM guidelines). HR and BP will be assessed to monitor for abnormal haemodynamic responses. Pre and post-exercise blood glucose will be assessed to ensure participants are normoglycaemic.

The protocol will be as follows:

kmh % grade
0.8 0
1.6 0
2.4 0
3.2 0
4.0 0
4.8 0
4.8 1
4.8 2
4.8 3

Protocol will continue at 4.8 kmh plus 1% each minute until termination criteria have been achieved.
Intervention code [1] 286515 0
Treatment: Other
Comparator / control treatment
Control subjects will receive 4g of maltodextrin placebo (oral capsules) once daily for 28 days. An incremental treadmill test will be performed pre- and post-intervention at four weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 288857 0
Exercise capacity as determined by an incremental treadmill protocol
Timepoint [1] 288857 0
Baseline and at 4 weeks
Secondary outcome [1] 301174 0
Insulin sensitivity: Determined from fasting glucose and insulin using the most recent HOMA2-IR calculator (version 2.2.2, Oxford University).
Timepoint [1] 301174 0
Baseline and at 4 weeks
Secondary outcome [2] 301175 0
Blood lipids (Total Cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides (TG) to be determined via standard enzymatic methods. LDL mathematically determined as total cholesterol minus HDL minus (0.45 x TG).
Timepoint [2] 301175 0
Baseline and at 4 weeks
Secondary outcome [3] 301176 0
Haemodynamics (Heart rate (HR), cardiac rhythm, and Blood Pressure (BP)): Seated blood pressure measured in duplicate on the left arm after 5 minutes rest on a standard hospital-grade sphygmomanometer. Exercise HR and cardiac rhythm determined by electrocardiogram.
Timepoint [3] 301176 0
Baseline and at 4 weeks
Secondary outcome [4] 301177 0
Diabetes Quality of Life Questionnaire
Timepoint [4] 301177 0
Baseline and at 4 weeks

Eligibility
Key inclusion criteria
Diagnosis of type 2 diabetes.
Medically stable and medically managed.
No documented cardiac history or stable cardiac history for previous 6 months.
No change in diabetes medications for previous two months.
Not currently taking exogenous insulin injections.
Signed consent from their general practitioner (GP) or specialist.
Minimum age
18 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Diabetic complications which may be worsened by exercise.
Change in medications during previous 2 months.
Unstable cardiovascular disease, stroke, or other conditions which might be worsened by exercise.
Lower limb injuries or chronic limb impairment which may preclude completion of a treadmill protocol.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 286730 0
University
Name [1] 286730 0
Southern Cross University
Country [1] 286730 0
Australia
Primary sponsor type
University
Name
Southern Cross University
Address
Military Road
Lismore, NSW 2480
Country
Australia
Secondary sponsor category [1] 285505 0
None
Name [1] 285505 0
Address [1] 285505 0
Country [1] 285505 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288802 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 288802 0
Ethics committee country [1] 288802 0
Australia
Date submitted for ethics approval [1] 288802 0
02/04/2013
Approval date [1] 288802 0
Ethics approval number [1] 288802 0

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

Contacts
Principal investigator
Name 37838 0
Dr William Sukala
Address 37838 0
PO Box 157
Lismore, NSW 2480
Country 37838 0
Australia
Phone 37838 0
+61-2-6626-9569
Fax 37838 0
Email 37838 0
[email protected]
Contact person for public queries
Name 37839 0
William Sukala
Address 37839 0
PO Box 157
Lismore, NSW 2480
Country 37839 0
Australia
Phone 37839 0
+61-2-6626-9569
Fax 37839 0
Email 37839 0
[email protected]
Contact person for scientific queries
Name 37840 0
William Sukala
Address 37840 0
PO Box 157
Lismore, NSW 2480
Country 37840 0
Australia
Phone 37840 0
+61-2-6626-9569
Fax 37840 0
Email 37840 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
No additional documents have been identified.