Metabolic SyndromeIMPARTNCT01230632
Metabolic Phenotyping of Individuals Born Following Assisted Reproduction Techniques
A study testing high fat overfeeding in people with Metabolic Syndrome and Diabetes, run by University of Adelaide at 1 site in Australia.
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). Read more about this study
- Who is it for?
- Ages 16 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Diabetes
- What is being tested?
- high fat overfeeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2010to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Post-pubertal healthy individuals aged 18-25years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Phenotyping of Individuals Born Following Assisted Reproduction
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.
Read the 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.
- Conditions
- Metabolic Syndrome, Diabetes
- Being tested
- high fat overfeeding
- Keywords
- assisted reproduction technology, Metabolic risk factors, In Vitro Fertilisation
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high fat overfeedingDietary supplement
Also called 3 days overfeeding
Dietary Supplement:3 days overfeeding
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement | Experimental | 3 days high fat food Receives: Dietary Supplement: high fat overfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 18 months
Secondary outcomes (1)
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Adelaide
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miaoxin Chen, University of Adelaide
- Investigators
- Leonie Heilbronn, PhD, Principal investigator, Department of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230632
- Sponsor's protocol ID
- 100510a
- Acronym
- IMPART
- Status last verified
- Dec 2013
- First submitted
- 28 Oct 2010
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27524654Chen 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.
PubMed 24760136
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Phenotyping of Individuals Born Following Assisted Reproduction
- ClinicalTrials.gov ID
- NCT01230632
- Acronym / sponsor ID
- IMPART / 100510a
- Conditions
- Metabolic Syndrome, Diabetes
- Keywords
- assisted reproduction technology, Metabolic risk factors, In Vitro Fertilisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of AdelaideUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 29 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement | Experimental | Dietary Supplement: high fat overfeeding3 days high fat food |
Who may qualify
- Ages
- 16 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Post-pubertal healthy individuals aged 18-25years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high fat overfeedingAlso: 3 days overfeedingDietary Supplement:3 days overfeeding | Dietary supplement | Dietary Supplement |
Primary outcome
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).
1 secondary outcome
insulin sensitivity
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
- Derived from this study: PubMed 27524654Chen 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.
- Derived from this study: PubMed 24760136Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonie Heilbronn, PhD principal investigator
Department of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high fat overfeeding in people with Metabolic Syndrome and Diabetes, run by University of Adelaide at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intravenous glucose tolerance test (IVGTT) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01230632, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2013.