White Adipose Tissue in Pregnancy Study

NCT ID: NCT02495987

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2025-03-31

Brief Summary

This study aims to understand the role of metabolic tissues in the changes of the metabolism of pregnant women and whether this contributes to some women developing metabolic diseases of pregnancy such as gestational diabetes (GDM) or intrahepatic cholestasis of pregnancy (ICP). Samples of adipose tissue will be taken when pregnant women are having caesarean section or laparoscopic procedures.

Detailed Description

There is a gradual change in metabolism in pregnancy. This is characterised by a switch from normal levels of cholesterol, glucose and bile acids in early pregnancy to high levels of lipids, glucose and bile acids in late pregnancy. This is important to ensure that nutrients are provided for the growing fetus. However, it results in some women developing metabolic diseases of pregnancy, e.g. gestational diabetes mellitus (GDM) or intrahepatic cholestasis of pregnancy (ICP).

This project aims to understand the role of metabolic tissues in the changes of the metabolism of pregnant women. The investigators are asking for permission to collect samples of adipose tissue (subcutaneous and visceral fat) when women are having surgical procedures. Specifically, the investigators would like to take small samples of fat at two time points:

1. When having a caesarean section (3rd trimester of pregnancy)

2. When having laparoscopic surgery for ectopic pregnancy (1st trimester of pregnancy) Samples will only be taken from women having surgery as part of their clinical care. The investigators are requesting permission to collect samples from women with metabolic diseases of pregnancy (GDM and ICP) and matched controls (women with uncomplicated pregnancy). The investigators will also want to collect blood samples.

There is evidence from non-pregnant individuals (and from animal studies) that the adipose tissue in different parts of the body function in different ways. Subcutaneous fat is typically a fat storage tissue while visceral adipose tissue plays a role in metabolism of fat. The investigators' studies in mice suggest that these different fat stores function differently in pregnancy, and they may play a role in the metabolic changes that cause dyslipidaemia and susceptibility to diabetes mellitus. The investigators aim to identify where there are similar changes in function of adipose tissue in human pregnancy, and whether this contributes to the development of GDM and ICP.

Conditions

ICP; GDM

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Pregnant women 18-50 years of age
• Uncomplicated pregnancies
• Pathological pregnancies such as Type II Diabetes and ICP

Exclusion Criteria

• Women treated with immunosuppressive agents, e.g. azathioprine.
• Type 1 diabetes mellitus.
• Long-standing treatment with glucocorticoids, e.g. prednisolone
• Hepatitis C, hepatitis B or HIV.
• Women unable to give consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Williamson, MBChB

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Guy's & St Thomas' NHS Foundation Trust

London, , United Kingdom

Imperial College Healthcare NHS Trust Hammersmith

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

14HH2393

Identifier Type: -

Identifier Source: org_study_id