Metabolic Phenotyping of Individuals Born Following Assisted Reproduction Techniques (IMPART)

This study is to compare the effects of high-fat overfeeding on metabolic risk factors in children born through assisted reproduction technologies (ART) versus children conceived naturally (controls). We will utilise state of the art measures to characterise the physiological, endocrine and molecular responses to high fat overfeeding.
The investigators hypothesise 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.

Official Title

Metabolic Phenotyping of Individuals Born Following Assisted Reproduction

Conditions

IVF

Study Type

Interventional

Study Design

Allocation: Randomised
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening

Further Details

Primary Outcome Measures:

• Metabolic Tests [ Time Frame: 20109-20119 ] [ Designated as safety issue: Yes ] IVGTT,hyperinsulinemic clamp

 

Secondary Outcome Measures:

• Clinical and Laboratory Tests [ Time Frame: 20109-20119 ] [ Designated as safety issue: No ] DEXA/MRI,Resting metabolic rate,insulin sensitivity,Gene expression

Arms:

Dietary Supplement: Experimental 3 days high fat food

Intervention: Dietary Supplement High-fat overfeeding

 

Assigned Interventions:

Dietary Supplement: high-fat overfeeding

Dietary Supplement: 3 days overfeeding

Other Name: 3 days overfeeding

Study Start

September 2010 – October 2011

Eligibility & Criteria

Ages Eligible for Study: 15 Years to 20 Years

Genders Eligible for Study: Both

Accepts Healthy Volunteers: Yes

 

Criteria

Inclusion Criteria:

• Post-pubertal healthy individuals aged 15-20years

 

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.

Total Enrolment

40

Contact Details

leonie heilbronn, PhD. Ph

82224900

leonie.heilbronn@adelaide.edu.au