Metabolic Phenotyping of Individuals Born Following Assisted Reproduction Techniques

Study Overview
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Brief Summary
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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.

Detailed Description
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This study represents a novel initiative by the investigators to determine whether children conceived through ART have different metabolic responses at baseline or in response to high fat overfeeding as compared to age and body mass index-matched spontaneously conceived controls. Furthermore, the investigators will identify any differences in DNA methylation of candidate genes involved in lipid metabolism in adipose tissue and blood, to determine whether this is related to adverse outcomes during high fat overfeeding. The results from this study will help answer growing questions of the future health of In vitro fertilisation (IVF) babies, and may stimulate further research into optimising protocols for ovarian stimulation or in-vitro conditions during early blastocyst development.

Official Title
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Metabolic Phenotyping of Individuals Born Following Assisted Reproduction

Conditions
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Metabolic Syndrome, Diabetes

Intervention / Treatment
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* Dietary Supplement: high fat overfeeding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-pubertal healthy individuals aged 18-25years 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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary Supplement<br>3 days high fat food | Dietary Supplement: high fat overfeeding<br>* Dietary Supplement:3 days overfeeding<br>* Other names: 3 days overfeeding;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intravenous glucose tolerance test (IVGTT) | After infusion of glucose bolus(0.3mg/kg, 50% glucose), blood samples are taken at 0,1,3,5,7,10,20,30 and 60 minutes. The value of glucose is recorded respectively (unit:mMol/L). | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin sensitivity | A 2-hour hyperinsulinemic euglycemic clamp (60mU/m2/min) is used to measure insulin sensitivity(µmol/min/kg Fat Free Mass). This is calculated by the formula from the amount of dextrose necessary to maintain blood glucose at 5mmol/L. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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assisted reproduction technology, Metabolic risk factors, In Vitro Fertilisation