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

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ClinicalTrials.gov Identifier: NCT01230632
Recruitment Status : Completed
First Posted : October 29, 2010
Last Update Posted : December 10, 2013
Information provided by (Responsible Party):
Miaoxin Chen, University of Adelaide

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Diabetes Dietary Supplement: high fat overfeeding Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Metabolic Phenotyping of Individuals Born Following Assisted Reproduction
Study Start Date : September 2010
Actual Primary Completion Date : April 2013
Actual Study Completion Date : September 2013

Arm Intervention/treatment
Experimental: Dietary Supplement
3 days high fat food
Dietary Supplement: high fat overfeeding
Dietary Supplement:3 days overfeeding
Other Name: 3 days overfeeding

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230632

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Australia, South Australia
Leonie Heilbronn
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
University of Adelaide
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Principal Investigator: Leonie Heilbronn, PhD Department of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Miaoxin Chen, Dr., University of Adelaide
ClinicalTrials.gov Identifier: NCT01230632    
Other Study ID Numbers: 100510a
First Posted: October 29, 2010    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2013
Keywords provided by Miaoxin Chen, University of Adelaide:
assisted reproduction technology
Metabolic risk factors
In Vitro Fertilisation
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases