Metabolic Phenotyping of Individuals Born Following Assisted Reproduction Techniques

Diabetes Clinical Trial

— IMPART  

Official title:

Metabolic Phenotyping of Individuals Born Following Assisted Reproduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01230632
• Other study ID #: 100510a
• Status: Completed
• Phase: N/A
• First received: October 28, 2010
• Last updated: December 7, 2013
• Start date: September 2010
• Est. completion date: September 2013

Study information

• Verified date: December 2013
• Source: University of Adelaide
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 26 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Dietary Supplement:
• high fat overfeeding
Dietary Supplement:3 days overfeeding

Locations

Country	Name	City	State
Australia	Leonie Heilbronn	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
University of Adelaide

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intravenous glucose tolerance test (IVGTT)	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	Yes
Secondary	insulin sensitivity	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	No