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CompletedNCT03317522HAPOUpdated Oct 23, 2017

Maternal Lipids and Offspring Adiposity at 5-7 Years

An observational study in Adiposity, sponsored by Belfast Health and Social Care Trust. Completed. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-23.

Sponsored by Belfast Health and Social Care Trust · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,224
Ages
18 Years and older
Sex
Female
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Study 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 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.

02

Conditions studied

  • Adiposity

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Keywords

  • Pregnancy
  • teratogenesis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Inclusion criteria

  • In a pregnant state in the first/second trimester
  • Attending the Royal Victoria Maternity Hospital

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,224 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

05

What researchers measure

Primary outcomes

  1. BMI Z score

    Adiposity expressed as body mass index (BMI) Z score

    Time frame: 5-7 years

  2. Sum of skin fold thicknesses

    Sum of triceps, subscapular and suprailiac

    Time frame: 5-7 years

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03317522
Lead sponsor
Belfast Health and Social Care Trust
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
First posted
Oct 23, 2017
Start date
Jan 9, 2001
Primary completion
Nov 4, 2006
Completion
Mar 14, 2012
Last update
Oct 23, 2017

Study contacts

David R McCance, MD
principal investigator · Belfast Health and Social Care Trust

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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