Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000378628
Ethics application status
Approved
Date submitted
7/09/2005
Date registered
13/09/2005
Date last updated
20/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Strength Training in Gestational Diabetes Mellitus (GDM)
Scientific title
The efficacy and feasibility of progressive strength training in the management of glucose control in women with gestational diabetes
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes 473 0
Condition category
Condition code
Metabolic and Endocrine 551 551 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supervised strength training program (twice a week)-45min. The duration of the intervention depends on the duration of pregnancy and the time of recruitment. We are recruiting women any time between 24 and 32 weeks of gestation and they stay in the program up until the birth. So the intervention period varies for each woman.
Intervention code [1] 384 0
Treatment: Other
Comparator / control treatment
Usual care (control)
Control group
Active

Outcomes
Primary outcome [1] 644 0
Change in fasting
Timepoint [1] 644 0
At one and a half hour post-prandial glucose between entry into the study and the week prior to delivery
Secondary outcome [1] 1333 0
Changes in HbA1c
Timepoint [1] 1333 0
Between entry into the study and the week prior to delivery.
Secondary outcome [2] 1334 0
Use of insulin, time until use of insulin, and insulin resistance.
Timepoint [2] 1334 0
Between entry into the study and the week prior to delivery.
Secondary outcome [3] 1335 0
Blood pressure
Timepoint [3] 1335 0
Between entry into the study and the week prior to delivery.
Secondary outcome [4] 1336 0
Muscle strength
Timepoint [4] 1336 0
Between entry into the study and the week prior to delivery.

Eligibility
Key inclusion criteria
Diagnosed GDM (after an overnight fast, women undergo a 75mg OGTT, GDM is diagnosed if fasting plasma glucose >/= 5.5, and/or 2hr plasma glucose >/= 8.0mmol/l), 24-32 weeks of gestation, primagravida or multigravida.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently/recently (preceding 2 months) engaged in a regular exercise, significant medical or obstetric conditions (history of hypertension, pre-eclampsia, premature rapture of membranes, premature labour, PV bleeding or an incompetent cervix).

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)
Sealed envelopes are held by an independent person, and opened by the independent person to assign the intervention group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers (Excel), in blocks.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 610 0
Other
Name [1] 610 0
International Diabetes Institute
Country [1] 610 0
Australia
Primary sponsor type
Other
Name
International Diabetes Institute
Address
250 kooyong Rd, VIC, 3165
Country
Australia
Secondary sponsor category [1] 497 0
None
Name [1] 497 0
None
Address [1] 497 0
Country [1] 497 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1702 0
Human Research Ethics Committee at the Monash Medical Centre
Ethics committee address [1] 1702 0
Ethics committee country [1] 1702 0
Australia
Date submitted for ethics approval [1] 1702 0
Approval date [1] 1702 0
Ethics approval number [1] 1702 0

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

Contacts
Principal investigator
Name 36169 0
Address 36169 0
Country 36169 0
Phone 36169 0
Fax 36169 0
Email 36169 0
Contact person for public queries
Name 9573 0
Mrs Elena Vulikh
Address 9573 0
International Diabetes Institute
250 Kooyong Rd
Caulfield Melbourne VIC 3162
Country 9573 0
Australia
Phone 9573 0
+61 3 92585000
Fax 9573 0
+61 3 92585902
Email 9573 0
evulikh@idi.org.au
Contact person for scientific queries
Name 501 0
A/Professor Jonathan Shaw
Address 501 0
International Diabetes Institute
250 Kooyong Rd
Caulfield Melbourne VIC 3162
Country 501 0
Australia
Phone 501 0
+61 3 92585000
Fax 501 0
+61 3 92585902
Email 501 0
jshaw@idi.org.au

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
EmbaseExercise for pregnant women with gestational diabetes for improving maternal and fetal outcomes.2017https://dx.doi.org/10.1002/14651858.CD012202.pub2
N.B. These documents automatically identified may not have been verified by the study sponsor.