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Metabolic Phenotyping of Individuals Born Following Assisted Reproduction Techniques

Metabolic Phenotyping of Individuals Born Following Assisted Reproduction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01230632
Acronym
IMPART
Enrollment
34
Registered
2010-10-29
Start date
2010-09-30
Completion date
2013-09-30
Last updated
2013-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Metabolic Syndrome

Keywords

assisted reproduction technology, Metabolic risk factors, In Vitro Fertilisation

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENThigh fat overfeeding

Dietary Supplement:3 days overfeeding

Sponsors

University of Adelaide
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 26 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
intravenous glucose tolerance test (IVGTT)18 monthsAfter 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

MeasureTime frameDescription
insulin sensitivity18 monthsA 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.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026