Metabolic Phenotyping of Individuals Born Following Assisted Reproduction Techniques (IMPART)
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|ClinicalTrials.gov Identifier: NCT01230632|
Recruitment Status : Completed
First Posted : October 29, 2010
Last Update Posted : December 10, 2013
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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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|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|
Experimental: Dietary Supplement
3 days high fat food
Dietary Supplement: high fat overfeeding
Dietary Supplement:3 days overfeeding
Other Name: 3 days overfeeding
- 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).
- 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.
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|Ages Eligible for Study:||16 Years to 26 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Post-pubertal healthy individuals aged 18-25years
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230632
|Australia, South Australia|
|Adelaide, South Australia, Australia, 5000|
|Principal Investigator:||Leonie Heilbronn, PhD||Department of Medicine|
|Responsible Party:||Miaoxin Chen, Dr., University of Adelaide|
|Other Study ID Numbers:||
|First Posted:||October 29, 2010 Key Record Dates|
|Last Update Posted:||December 10, 2013|
|Last Verified:||December 2013|
assisted reproduction technology
Metabolic risk factors
In Vitro Fertilisation
Glucose Metabolism Disorders