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

Primary Purpose

Metabolic Syndrome, Diabetes

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
high fat overfeeding
Sponsored by
University of Adelaide
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Metabolic Syndrome focused on measuring assisted reproduction technology, Metabolic risk factors, In Vitro Fertilisation

Eligibility Criteria

16 Years - 26 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Leonie Heilbronn

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dietary Supplement

Arm Description

3 days high fat food

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
October 28, 2010
Last Updated
December 7, 2013
Sponsor
University of Adelaide
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1. Study Identification

Unique Protocol Identification Number
NCT01230632
Brief Title
Metabolic Phenotyping of Individuals Born Following Assisted Reproduction Techniques
Acronym
IMPART
Official Title
Metabolic Phenotyping of Individuals Born Following Assisted Reproduction
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Adelaide

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Diabetes
Keywords
assisted reproduction technology, Metabolic risk factors, In Vitro Fertilisation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary Supplement
Arm Type
Experimental
Arm Description
3 days high fat food
Intervention Type
Dietary Supplement
Intervention Name(s)
high fat overfeeding
Other Intervention Name(s)
3 days overfeeding
Intervention Description
Dietary Supplement:3 days overfeeding
Primary Outcome Measure Information:
Title
intravenous glucose tolerance test (IVGTT)
Description
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).
Time Frame
18 months
Secondary Outcome Measure Information:
Title
insulin sensitivity
Description
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.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonie Heilbronn, PhD
Organizational Affiliation
Department of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leonie Heilbronn
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
27524654
Citation
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.
Results Reference
derived
PubMed Identifier
24760136
Citation
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.
Results Reference
derived

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Metabolic Phenotyping of Individuals Born Following Assisted Reproduction Techniques

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