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

December 7, 2013 updated by: Miaoxin Chen, University of Adelaide

Metabolic Phenotyping of Individuals Born Following Assisted Reproduction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Leonie Heilbronn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 26 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dietary Supplement
3 days high fat food
Dietary supplement: high fat overfeeding
Dietary Supplement:3 days overfeeding
Other Names:
  • 3 days overfeeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Adelaide

Investigators

  • Principal Investigator: Leonie Heilbronn, PhD, Department of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

October 28, 2010

First Submitted That Met QC Criteria

October 28, 2010

First Posted (ESTIMATE)

October 29, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 10, 2013

Last Update Submitted That Met QC Criteria

December 7, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100510a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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