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Metabolic Phenotyping of Individuals Born Following Assisted Reproduction Techniques

NCT ID: NCT01230632

Last Updated: 2013-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-09-30

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.

Conditions

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Metabolic Syndrome Diabetes

Keywords

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assisted reproduction technology Metabolic risk factors In Vitro Fertilisation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Dietary Supplement

3 days high fat food

Group Type EXPERIMENTAL

high fat overfeeding

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement:3 days overfeeding

Interventions

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high fat overfeeding

Dietary Supplement:3 days overfeeding

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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3 days overfeeding

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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Adelaide

OTHER

Sponsor Role lead

Responsible Party

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Miaoxin Chen

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leonie Heilbronn, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine

Locations

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Leonie Heilbronn

Adelaide, South Australia, Australia

Site Status

Countries

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Australia

References

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Chen M, Liu B, Wilkinson D, Hutchison AT, Thompson CH, Wittert GA, Heilbronn LK. Selenoprotein P is elevated in individuals with obesity, but is not independently associated with insulin resistance. Obes Res Clin Pract. 2017 Mar-Apr;11(2):227-232. doi: 10.1016/j.orcp.2016.07.004. Epub 2016 Aug 11.

Reference Type DERIVED
PMID: 27524654 (View on PubMed)

Chen M, Wu L, Zhao J, Wu F, Davies MJ, Wittert GA, Norman RJ, Robker RL, Heilbronn LK. Altered glucose metabolism in mouse and humans conceived by IVF. Diabetes. 2014 Oct;63(10):3189-98. doi: 10.2337/db14-0103. Epub 2014 Apr 23.

Reference Type DERIVED
PMID: 24760136 (View on PubMed)

Other Identifiers

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100510a

Identifier Type: -

Identifier Source: org_study_id