An observational study in ICP and GDM, sponsored by Imperial College London. Active, not recruiting at 2 sites in United Kingdom. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by Imperial College London · Observational
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.
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:
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.
Imperial College London is the lead sponsor of 842 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Pregnant women with or without ICP or GDM
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Exclusion Criteria:
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
Alterations in subcutaneous and visceral fat messenger RNA (mRNA) will be measured using quantitative PCR by fold-change mRNA expression in reference to the control group: normal pregnancy).
Time frame: 10 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.
Altered levels of incretins will be measured by either quantitative PCR looking at mRNA expression of target genes (measured in fold-change mRNA expression in reference to the control group: normal pregnancy), or through metabolite (lipid species) assessment by mass spectrometry, measured in absolute concentration of lipid species per mg fat.
Time frame: 10 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
Changes in histological appearance will be assess through hematoxylin and eosin staining. Adipocyte area will be quantified using ImageJ to determine mean, median, range and distribution of adipocytes for each group. Smaller adipocytes typically indicates either reduced lipid uptake, increased lipid export or hyperplasia
Time frame: 10 years
Plan to share: No — We will publish our results and findings in research publications.
No publications or documents are linked to this record.
The record gives a start of Mar 2015, a primary completion of Mar 2025 and a completion of Mar 2025. It does not say whether these dates are actual or estimated.
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This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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