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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

Tracking Information
First Submitted Date  ICMJE October 28, 2010
First Posted Date  ICMJE October 29, 2010
Last Update Posted Date December 10, 2013
Study Start Date  ICMJE September 2010
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2011)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2010)
Metabolic Tests [ Time Frame: 2010\9-2011\9 ]
IVGTT,hyperinsulinemic clamp
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2011)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2010)
Clinical and Laboratory Tests [ Time Frame: 2010\9-2011\9 ]
DEXA/MRI,Resting metabolic rate,insulin sensitivity,Gene expression
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Metabolic Phenotyping of Individuals Born Following Assisted Reproduction Techniques
Official Title  ICMJE Metabolic Phenotyping of Individuals Born Following Assisted Reproduction
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Metabolic Syndrome
  • Diabetes
Intervention  ICMJE Dietary Supplement: high fat overfeeding
Dietary Supplement:3 days overfeeding
Other Name: 3 days overfeeding
Study Arms  ICMJE Experimental: Dietary Supplement
3 days high fat food
Intervention: Dietary Supplement: high fat overfeeding
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2013)
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2010)
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 26 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01230632
Other Study ID Numbers  ICMJE 100510a
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Miaoxin Chen, University of Adelaide
Original Responsible Party Associate Professor Leonie Heilbronn, Department of Medicine of the University of Adelaide
Current Study Sponsor  ICMJE University of Adelaide
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leonie Heilbronn, PhD Department of Medicine
PRS Account University of Adelaide
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP