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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Other interventions - high fat overfeeding

Experimental: Dietary Supplement - 3 days high fat food


Other interventions: high fat overfeeding
Dietary Supplement:3 days overfeeding
Intervention code [1] 0 0
Other interventions
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
Health Services Research
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
This study is to compare the effects of high fat overfeeding on metabolic risk factors in
children born though assisted reproduction technologies (ART) versus children conceived
naturally (controls). The investigators will utilize state of the ART measures to
characterize the physiological, endocrine and molecular responses to high fat overfeeding.

The investigators hypothesize that children conceived following ART will have greater
responses to high fat dietary challenge and that this will be associated with DNA
hypermethylation of genes that are involved in lipid metabolism.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01230632
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01230632