Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000832774
Ethics application status
Approved
Date submitted
25/07/2013
Date registered
29/07/2013
Date last updated
1/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of post-meal walking on glycaemic variability in people with type 2 diabetes
Scientific title
Post-meal walking for people with type 2 diabetes to assess the effect on glycaemic variability
Secondary ID [1] 282905 0
Nil
Universal Trial Number (UTN)
U1111-1145-9707
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 289719 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290046 290046 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will advise and support people with type 2 diabetes to adhere to two physical activity regimens in a crossover design, each regimen lasting two weeks with a one month washout between treatment periods. One regimen is to follow the established Diabetes New Zealand guideline of “30 minutes brisk walking most days”. The other regimen is to undertake three 10-minute walks per day, each walk commencing shortly after breakfast, lunch and dinner. Following the crossover period of the trial, participants will be invited to continue with the post-meal walking for a further three months with continuing support and motivation from the study investigators. The justification for post-meal walking is evidence of a reduction in peak glucose concentrations compared with being sedentary after eating in pre-diabetics, as measured by parameters captured with continuous glucose monitoring systems (CGMS). The 3-month follow-up will allow for changes in glycated haemoglobin, a longer-term measure of glycaemic control to be assessed, as well as a better understanding of supported environments in disease management. The study’s quantitative framework is a valuable opportunity to concurrently assess qualitative impacts on diabetes management and treatment.
Intervention code [1] 287603 0
Lifestyle
Comparator / control treatment
This is a randomized crossover study in which glycaemic responses will be compared between two walking regimens. The novel intervention, 3 bouts of 10 minutes post-meal walking each day will be compared with the control, 30 minutes of continuous walking per day unattached to an eating period as currently recommended by Diabetes New Zealand.
Control group
Active

Outcomes
Primary outcome [1] 290097 0
Postprandial blood glucose area-under-the-curve assessed using a continuous glucose monitoring system providing an interstitial glucose reading every five minutes. The area between the mean overnight blood glucose concentration and the post-meal response curve over three hours will be quantified using the trapezoidal method.
Timepoint [1] 290097 0
Interstitial glucose measurements taken every 5 minutes for a period of 7 days. Post meal 3-h area-under-the-curve will be recorded over the second week of the two 15 day interventions.
Primary outcome [2] 290098 0
Glycated albumin concentration measured in a blood sample using a proprietary glycated albumin assay kit. There are a number of possible kits; the particular brand is yet to be determined. Precision and accuracy of the assay will be determined according to the manufacturers recommendation.
Timepoint [2] 290098 0
Venous blood concentration of glycated albumin taken at the end of each activity arm
Secondary outcome [1] 303934 0
Glycated haemoglobin concentration measured in a blood sample using a proprietary analyser kit. Precision and accuracy of the test will be measured in accordance with manufacturers recommendations
Timepoint [1] 303934 0
Venous blood concentration of glycated haemoglobin taken pre- and post- three month activity intervention
Secondary outcome [2] 303935 0
Changes in attitude towards and perception of physical activity guidelines and disease management. The measurement tools will be those validated by the Stanford Patient Education Research Center, USA. Physical activity will be assessed using the short form New Zealand Physical Activity Questionnaire (NZPAQ).
Timepoint [2] 303935 0
Perception of physical activity guidelines and disease management will be assessed at baseline, after receiving personalised glycaemic data and after a supported 3-month period of post meal walking.
Secondary outcome [3] 303936 0
Measures of glycaemic variability assessed using a continuous glucose monitoring system providing an interstitial glucose reading every five minutes. The measures involved are Mean Amplitude of the Glycaemic Excursion (MAGE), Mean Absolute Glucose (MAG), time spent in hyperglycaemia and the mean blood glucose concentration.
Timepoint [3] 303936 0
Glycaemic variability assessed over the two periods of the different activity regimens. Glycaemic variability will be monitored over 6-days on each activity regimen. Comparisons will be made between the two activity regimens at the end of the crossover period.
Secondary outcome [4] 303937 0
Fasting insulin concentrations will be measured in a blood sample using a proprietary insulin kit. Precision and accuracy of the test will be measured in accordance with manufacturers recommendations.
Timepoint [4] 303937 0
Fasting insulin concentrations will be taken at the end of each activity regimen

Eligibility
Key inclusion criteria
Type 2 diabetes
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to walk for 30 minutes per day

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)
Volunteers will respond to advertisement and be given an information sheet in which the aims and procedures of the study are described. Allocation to treatment order will be computer-generated so that neither the participant nor the investigator is aware of treatment order at enrolment. ie: the person who determined if a subject was eligible for inclusion in the trial was unaware as to whether the person would start on the control or intervention physical activity regimen before swapping over to the alternative.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was determined by a power calculation at an alpha of 0.05 and power of 0.80 to detect between-intervention differences in the primary outcome variables; a clinically relevant 20% difference in postprandial glycaemia and a 10% difference in glycated albumin. Data will assessed for normal distribution and transformed if necessary. ANOVA will be used to test for differences in glycaemia between treatments

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/08/2013
Actual
Date of last participant enrolment
Anticipated
1/07/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment outside Australia
Country [1] 5247 0
New Zealand
State/province [1] 5247 0
Otago

Funding & Sponsors
Funding source category [1] 287686 0
University
Name [1] 287686 0
University of Otago
Country [1] 287686 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56
Dunedin
Country
New Zealand
Secondary sponsor category [1] 286419 0
None
Name [1] 286419 0
Address [1] 286419 0
Country [1] 286419 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289645 0
University of Otago Ethics Committee (Health)
Ethics committee address [1] 289645 0
Ethics committee country [1] 289645 0
New Zealand
Date submitted for ethics approval [1] 289645 0
08/07/2013
Approval date [1] 289645 0
23/07/2013
Ethics approval number [1] 289645 0
University of Otago H13/039

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

Contacts
Principal investigator
Name 41746 0
Dr Bernard Venn
Address 41746 0
University of Otago
Department of Human Nutrition
PO Box 56
Dunedin
Country 41746 0
New Zealand
Phone 41746 0
+6434795068
Fax 41746 0
Email 41746 0
[email protected]
Contact person for public queries
Name 41747 0
Bernard Venn
Address 41747 0
University of Otago
Department of Human Nutrition
PO Box 56
Dunedin
Country 41747 0
New Zealand
Phone 41747 0
+6434795068
Fax 41747 0
Email 41747 0
[email protected]
Contact person for scientific queries
Name 41748 0
Bernard Venn
Address 41748 0
University of Otago
Department of Human Nutrition
PO Box 56
Dunedin
Country 41748 0
New Zealand
Phone 41748 0
+6434795068
Fax 41748 0
Email 41748 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 AIAdvice to walk after meals is more effective for lowering postprandial glycaemia in type 2 diabetes mellitus than advice that does not specify timing: a randomised crossover study2016https://doi.org/10.1007/s00125-016-4085-2
N.B. These documents automatically identified may not have been verified by the study sponsor.