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NCT Number: NCT01230632

Metabolic Phenotyping of Individuals Born Following Assisted Reproduction Techniques

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.

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Key information

Conditions

Metabolic Syndrome Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

16 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leonie Heilbronn

Adelaide, South Australia, 5000, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

high fat overfeeding

Dietary Supplement

Dietary Supplement:3 days overfeeding

Other names: 3 days overfeeding

Primary outcomes

  1. intravenous glucose tolerance test (IVGTT)

    Time frame: 18 months

    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).

Secondary outcomes

  1. insulin sensitivity

    Time frame: 18 months

    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.

Sponsors and collaborators

Lead sponsor

University of Adelaide

Other

Registry information

Official study title

Metabolic Phenotyping of Individuals Born Following Assisted Reproduction

Acronym: IMPART

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 29, 2010
Registry last updated
Dec 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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