Metabolic Phenotyping of Individuals Born Following Assisted Reproduction Techniques

NCT01230632 | Completed DMC

• 1 other identifier: 100510a
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Diabetes

Keywords

assisted reproduction technology; Metabolic risk factors; In Vitro Fertilisation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• insulin sensitivity

  18 months

Study Arms (1)

Dietary Supplement

EXPERIMENTAL

3 days high fat food

Dietary Supplement: high fat overfeeding

Interventions

high fat overfeeding DIETARY_SUPPLEMENT

Dietary Supplement:3 days overfeeding

Also known as: 3 days overfeeding

Dietary Supplement

Eligibility Criteria

• Age: 16 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Post-pubertal healthy individuals aged 18-25years

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Adelaide: lead

Study Sites (1)

Leonie Heilbronn

Adelaide, South Australia, 5000, Australia

Location

Related Publications (2)

• 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.

  PMID: 27524654 DERIVED

• 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.

  PMID: 24760136 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Leonie Heilbronn, PhD

  Department of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: October 29, 2010
• Study Start: September 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 10, 2013

Record last verified: 2013-12

Locations

AU (1)