AdiposityHAPONCT03317522
Maternal Lipids and Offspring Adiposity at 5-7 Years
An observational study of Adiposity, run by Belfast Health and Social Care Trust.
Trial summary
This study investigates the associations between measured maternal lipids (Total cholesterol, LDL-cholesterol , triglycerides and high-density lipoprotein cholesterol) at 28 weeks' gestation and offspring adiposity at 5-7 years. This was examined in a large observational study based in Belfast, UK. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adiposity
- Type of treatment
- Pill or oral medicine
- How many people
- 1,224 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2001to 14 Mar 2012
- Phase
- Observational
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All pregnant women who attended the Royal Victoria Maternity Hospital were eligible to participate unless they met one or more of the exclusion criteria.
Who may be able to join
- In a pregnant state in the first/second trimester
- Attending the Royal Victoria Maternity Hospital
Who cannot join
- Age younger than 18 years
- A plan to undergo delivery at another hospital
- An uncertain date of last menstrual period and no ultrasonographic estimation between 6 and 24 weeks of gestational age
- Inability to complete the oral glucose-tolerance test within 32 weeks of gestation
- Multiple pregnancy
- Conception by means of gonadotropin ovulation induction or in vitro fertilization
Show all 12Show fewer
- Glucose testing before recruitment or a diagnosis of diabetes during the current pregnancy
- Diagnosis of diabetes before the current pregnancy and requiring treatment with medication
- Participation in another study that could interfere with the HAPO study
- Infection with the human immunodeficiency virus or hepatitis B or C virus
- Previous participation in the HAPO study
- Inability to converse in the languages used on centre forms without the aid of an interpreter
About this study
Official title: Maternal Lipids at 28 Weeks Gestation and Offspring Adiposity at Age 5-7 Years in the Hyperglycemia and Adverse Pregnancy Outcome Study
This study investigates the associations between measured maternal lipids (Total cholesterol, LDL-cholesterol , triglycerides and high-density lipoprotein cholesterol) at 28 weeks' gestation and offspring adiposity at 5-7 years. This was examined in a large observational study based in Belfast, UK.
Read the detailed description
The concept of fuel mediated teratogenesis, as proposed by Freinkel in his 1980 Banting Lecture, postulated that altered fuel metabolism during pregnancy had a long lasting metabolic effect on the offspring. Although in the intervening years the focus has largely been on maternal glucose as the principal fetal fuel, animal studies have documented that other nutrients such as lipids can also be transferred across the placenta. Furthermore, the latter part of pregnancy is associated with a significant hyperlipidemia including hypercholesterolemia and hypertriglyceridemia. Although the relation of maternal lipids during pregnancy to birth outcomes is well documented, few studies have examined this relation to longer term outcomes. Such an association, if present, would lend further support to the presence of developmental programming in the offspring based on fuel mediated teratogenesis.
Against such a background, the aim of this study was to examine the association between maternal lipids during pregnancy and later offspring adiposity controlled for relevant confounders including maternal body mass index (BMI), gestational glycemia and offspring birth weight.
The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study was an international multicentre epidemiologic study that examined the associations of hyperglycemia during pregnancy to adverse maternal/fetal pregnancy outcomes. Eligible pregnant women attended the Royal Victoria Maternity Hospital for an oral glucose tolerance test between 24-32 weeks gestation to assess glucose tolerance. An additional fasting serum sample for analysis of lipids was taken.
The mothers and their offspring were invited to return to the study 5-7 years later. At this visit, offspring weight, height and skin fold thickness measurements were taken.
- Conditions
- Adiposity
- Keywords
- Pregnancy, teratogenesis
- Medical subject headings
- Obesity, Teratogenesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Belfast HAPO | All pregnant women who attended the Royal Victoria Maternity Hospital, Belfast were eligible to participate unless they met one or more exclusion criteria. All eligible women from the Belfast centre were invited to take part in a prospective observational study involving an additional fasting serum sample for lipids at 28 weeks gestation and long term follow up of their HAPO offspring. Only those women who had remained blinded to oral glucose tolerance test (OGTT) results during pregnancy were included (fasting plasma glucose ≤5·8 mmol/L and 2-hour glucose ≤11·1 mmol/L). Offspring from these pregnancies had anthropometric measurements performed within 72 hours of birth and at age 5-7 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI Z score
Adiposity expressed as body mass index (BMI) Z score
Measured: 5-7 years
Sum of skin fold thicknesses
Sum of triceps, subscapular and suprailiac
Measured: 5-7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start9 Jan 2001
- Primary completion4 Nov 2006
- Study completion14 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdiposityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Diabetes UK
- Responsible party
- Sponsor
- Investigators
- David R McCance, MD, Principal investigator, Belfast Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317522
- Sponsor's protocol ID
- BelfastHSCT
- Other IDs
- R01HD034242
- Acronym
- HAPO
- Status last verified
- Oct 2017
- First submitted
- 10 Oct 2017
- Last updated
- 23 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Lipids at 28 Weeks Gestation and Offspring Adiposity at Age 5-7 Years in the Hyperglycemia and Adverse Pregnancy Outcome Study
- ClinicalTrials.gov ID
- NCT03317522
- Acronym / sponsor ID
- HAPO / BelfastHSCT
- Conditions
- Adiposity
- Keywords
- Pregnancy, teratogenesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,224 participants (actual)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Diabetes UK
- Study start
- 9 Jan 2001 (actual)
- Primary completion
- 4 Nov 2006 (actual)
- Study completion
- 14 Mar 2012 (actual)
- First posted
- 23 Oct 2017 (actual)
- 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 investigates the associations between measured maternal lipids (Total cholesterol, LDL-cholesterol , triglycerides and high-density lipoprotein cholesterol) at 28 weeks' gestation and offspring adiposity at 5-7 years. This was examined in a large observational study based in Belfast, UK.
Detailed description
The concept of fuel mediated teratogenesis, as proposed by Freinkel in his 1980 Banting Lecture, postulated that altered fuel metabolism during pregnancy had a long lasting metabolic effect on the offspring. Although in the intervening years the focus has largely been on maternal glucose as the principal fetal fuel, animal studies have documented that other nutrients such as lipids can also be transferred across the placenta. Furthermore, the latter part of pregnancy is associated with a significant hyperlipidemia including hypercholesterolemia and hypertriglyceridemia. Although the relation of maternal lipids during pregnancy to birth outcomes is well documented, few studies have examined this relation to longer term outcomes. Such an association, if present, would lend further support to the presence of developmental programming in the offspring based on fuel mediated teratogenesis.
Against such a background, the aim of this study was to examine the association between maternal lipids during pregnancy and later offspring adiposity controlled for relevant confounders including maternal body mass index (BMI), gestational glycemia and offspring birth weight.
The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study was an international multicentre epidemiologic study that examined the associations of hyperglycemia during pregnancy to adverse maternal/fetal pregnancy outcomes. Eligible pregnant women attended the Royal Victoria Maternity Hospital for an oral glucose tolerance test between 24-32 weeks gestation to assess glucose tolerance. An additional fasting serum sample for analysis of lipids was taken.
The mothers and their offspring were invited to return to the study 5-7 years later. At this visit, offspring weight, height and skin fold thickness measurements were taken.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Belfast HAPO | – | –All pregnant women who attended the Royal Victoria Maternity Hospital, Belfast were eligible to participate unless they met one or more exclusion criteria. All eligible women from the Belfast centre were invited to take part in a prospective observational study involving an additional fasting serum sample for lipids at 28 weeks gestation and long term follow up of their HAPO offspring. Only those women who had remained blinded to oral glucose tolerance test (OGTT) results during pregnancy were included (fasting plasma glucose ≤5·8 mmol/L and 2-hour glucose ≤11·1 mmol/L). Offspring from these pregnancies had anthropometric measurements performed within 72 hours of birth and at age 5-7 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All pregnant women who attended the Royal Victoria Maternity Hospital were eligible to participate unless they met one or more of the exclusion criteria.
Key inclusion criteria (2 listed)
- In a pregnant state in the first/second trimester
- Attending the Royal Victoria Maternity Hospital
Key exclusion criteria (12 listed)
- Age younger than 18 years
- A plan to undergo delivery at another hospital
- An uncertain date of last menstrual period and no ultrasonographic estimation between 6 and 24 weeks of gestational age
- Inability to complete the oral glucose-tolerance test within 32 weeks of gestation
- Multiple pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BMI Z score
Time frame: 5-7 years
Adiposity expressed as body mass index (BMI) Z score
Sum of skin fold thicknesses
Time frame: 5-7 years
Sum of triceps, subscapular and suprailiac
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 23 Oct 2017.
- Individual participant dataSharing planned: No
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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.
David R McCance, MD principal investigator
Belfast Health and Social Care Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Adiposity, run by Belfast Health and Social Care Trust.
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 2 inclusion and 12 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 23 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
BMI Z score (time frame: 5-7 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2017.