White Adipose Tissue in Pregnancy Study (WAT)
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|ClinicalTrials.gov Identifier: NCT02495987|
Recruitment Status : Recruiting
First Posted : July 14, 2015
Last Update Posted : April 16, 2019
|Condition or disease|
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:
- When having a caesarean section (3rd trimester of pregnancy)
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Adaptations in Subcutaneous and Visceral Adipose Tissue Metabolism During Normal and Pathological Pregnancies|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||February 9, 2020|
|Estimated Study Completion Date :||February 9, 2020|
- To establish whether there is altered function of subcutaneous and visceral fat in the 1st or 3rd trimester of normal pregnancy, ICP or GDM and whether this is associated with alterations in serum lipids and bile acids [ Time Frame: 3 years ]
- To establish whether there are changes in subcutaneous or visceral fat function associated with altered levels of incretins, free fatty acids or other metabolites of relevance to bile acid, lipid or glucose metabolism. [ Time Frame: 3 years ]
- To establish whether there are changes in the histological appearance of subcutaneous or visceral fat in the first or third trimester of normal pregnancy, ICP or GDM [ Time Frame: 3 years ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02495987
|Contact: Jenny Chambers||0208 383 email@example.com|
|Guy's & St Thomas' NHS Foundation Trust||Recruiting|
|London, United Kingdom, SE1 7EH|
|Contact: Jenny Chambers 0208 3835285 firstname.lastname@example.org|
|Imperial College Healthcare NHS Trust Hammersmith||Recruiting|
|London, United Kingdom|
|Contact: Jenny Chambers 0208 3835285|
|Principal Investigator:||Catherine Williamson, MBChB||Imperial College London|