Maternal Lipids and Offspring Adiposity at 5-7 Years

NCT03317522 | Completed

• 2 other identifiers: BelfastHSCTR01HD034242
• Study Type: observational
• Target: 1,224
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Adiposity

Keywords

Pregnancy; teratogenesis

Outcome Measures

Primary Outcomes (2)

• BMI Z score

  Adiposity expressed as body mass index (BMI) Z score

  5-7 years

• Sum of skin fold thicknesses

  Sum of triceps, subscapular and suprailiac

  5-7 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants had to be pregnant to take part in study and therefore only female participants could be selected.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Belfast Health and Social Care Trust: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Diabetes UK: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples remain for a number of participants.

MeSH Terms

Conditions

Obesity; Teratogenesis

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• David R McCance, MD

  Belfast Health and Social Care Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 23, 2017
• Study Start: January 9, 2001
• Primary Completion: November 4, 2006
• Study Completion: March 14, 2012
• Last Updated: October 23, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share