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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 26 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Australia, South Australia

Leonie Heilbronn

Adelaide, South Australia, Australia, 5000

Sponsors and Collaborators

University of Adelaide

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Miaoxin Chen, Dr., University of Adelaide
• ClinicalTrials.gov Identifier: NCT01230632
• Other Study ID Numbers: 100510a
• First Posted: October 29, 2010
• 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:

Metabolic Syndrome; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases