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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01230632




Registration number
NCT01230632
Ethics application status
Date submitted
28/10/2010
Date registered
29/10/2010
Date last updated
10/12/2013

Titles & IDs
Public title
Metabolic Phenotyping of Individuals Born Following Assisted Reproduction Techniques
Scientific title
Metabolic Phenotyping of Individuals Born Following Assisted Reproduction
Secondary ID [1] 0 0
100510a
Universal Trial Number (UTN)
Trial acronym
IMPART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome 0 0
Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - high fat overfeeding

Experimental: Dietary Supplement - 3 days high fat food


Treatment: Other: high fat overfeeding
Dietary Supplement:3 days overfeeding
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
intravenous glucose tolerance test (IVGTT)
Timepoint [1] 0 0
18 months
Secondary outcome [1] 0 0
insulin sensitivity
Timepoint [1] 0 0
18 months

Eligibility
Key inclusion criteria
* Post-pubertal healthy individuals aged 18-25years
Minimum age
16 Years
Maximum age
26 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Participants are ineligible if they have any significant medical conditions (e.g. personal history or clinical manifestation of cardiovascular disease, type 2 diabetes),
* strong family histories of diabetes or cardiovascular disease (e.g. first-degree relatives),
* take concomitant medications (eg: metformin),
* if they smoke or drink >140g of alcohol/week, , or
* were born prematurely (<37 weeks), or
* from mothers who had gestational diabetes.

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2013
Sample size
Target
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Leonie Heilbronn - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Leonie Heilbronn, PhD
Address 0 0
Department of Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01230632