Maternal Lipids and Offspring Adiposity at 5-7 Years

Adiposity Clinical Trial

— HAPO  

Official title:

Maternal Lipids at 28 Weeks Gestation and Offspring Adiposity at Age 5-7 Years in the Hyperglycemia and Adverse Pregnancy Outcome Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03317522
• Other study ID #: BelfastHSCT
• Secondary ID: R01HD034242
• Status: Completed
• Phase: N/A
• First received: October 10, 2017
• Last updated: October 20, 2017
• Start date: January 9, 2001
• Est. completion date: March 14, 2012

Study information

• Verified date: October 2017
• Source: Belfast Health and Social Care Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1224
• Est. completion date: March 14, 2012
• Est. primary completion date: November 4, 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• In a pregnant state in the first/second trimester

• Attending the Royal Victoria Maternity Hospital

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

Related Conditions & MeSH terms

• Adiposity
• Obesity

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Belfast Health and Social Care Trust	Diabetes UK, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI Z score	Adiposity expressed as body mass index (BMI) Z score	5-7 years
Primary	Sum of skin fold thicknesses	Sum of triceps, subscapular and suprailiac	5-7 years