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

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

Tracking Information

• First Submitted Date: October 28, 2010
• First Posted Date: October 29, 2010
• Last Update Posted Date: December 10, 2013
• Study Start Date: September 2010
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: October 28, 2010)

Metabolic Tests [ Time Frame: 2010\9-2011\9 ]

IVGTT,hyperinsulinemic clamp

Current Secondary Outcome Measures (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 (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: Metabolic Phenotyping of Individuals Born Following Assisted Reproduction Techniques
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research

Condition

• Metabolic Syndrome
• Diabetes

Intervention

Dietary Supplement: high fat overfeeding

Dietary Supplement:3 days overfeeding

Other Name: 3 days overfeeding

Study Arms

Experimental: Dietary Supplement

3 days high fat food

Intervention: Dietary Supplement: high fat overfeeding

Publications *

• Chen M, Liu B, Wilkinson D, Hutchison AT, Thompson CH, Wittert GA, Heilbronn LK. Selenoprotein P is elevated in individuals with obesity, but is not independently associated with insulin resistance. Obes Res Clin Pract. 2017 Mar-Apr;11(2):227-232. doi: 10.1016/j.orcp.2016.07.004. Epub 2016 Aug 11.
• Chen M, Wu L, Zhao J, Wu F, Davies MJ, Wittert GA, Norman RJ, Robker RL, Heilbronn LK. Altered glucose metabolism in mouse and humans conceived by IVF. Diabetes. 2014 Oct;63(10):3189-98. doi: 10.2337/db14-0103. Epub 2014 Apr 23.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 7, 2013): 34
• Original Estimated Enrollment (submitted: October 28, 2010): 40
• Actual Study Completion Date: September 2013
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 16 Years to 26 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT01230632
• Other Study ID Numbers: 100510a
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: 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: University of Adelaide
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Adelaide
• Verification Date: December 2013