The Metabolic Profile in Intrahepatic Cholestasis of Pregnancy and Diabetes Mellitus
ICP is known to cause abnormal bile acid homeostasis and to be associated with an increased risk of diseases of the biliary system in later life. There have been small studies (Dann et al. 2006; Wójcicka-Jagodzińska et al. 1989) suggesting that it causes dyslipidaemia (raised lipids) and impaired glucose tolerance in pregnancy. However the underlying mechanisms of these abnormalities is not known. Similarly the influence of cholestasis on fetal metabolism is not known, and nor is the role of the placenta. It is also not known whether women with ICP have a predisposition to abnormal lipid and glucose homeostasis when they are not pregnant.
GDM is characterized by raised plasma glucose levels in pregnant women (in the absence of pre-pregnancy diabetes mellitus). This condition is associated with large-for-gestational age babies and obstructed labour. Women with GDM have increased risk of subsequent type 2 diabetes mellitus, and if they have this condition in a subsequent pregnancy there is an increased risk of stillbirth. This work is important to understand the causes of the metabolic abnormalities associated with ICP and GDM. If we demonstrate abnormal lipid and glucose profiles, these may be of relevance to the fetal complications of both disorders. It will also be of relevance to the future health of affected women and their children.
Intrahepatic Cholestasis of Pregnancy (ICP), Gestational Diabetes Mellitus (GDM)
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||A Longitudinal Study of Alterations in Metabolic Markers and Gut Hormones in Pregnant and Non-pregnant Patients With Intrahepatic Cholestasis of Pregnancy, Gestational Diabetes Mellitus and Normal Pregnant and Non-pregnant Controls|
- To establish whether raised serum bile acids are associated with abnormalities in cholesterol and triglycerides in the mother and fetus mother and fetus. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- To establish the relationship between raised serum bile acids in the mother and fetus and abnormalities in: Glucose homeostasis, gut liver signaling hormones related to FGF 19 and C4 levels, Gut hormone secretion [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Serum, whole blood, plasma.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499524
|Contact: Jenny Chambers||020 8383 firstname.lastname@example.org|
|Imperial College Healthcare NHS Trust Hammersmith||Recruiting|
|London, United Kingdom|
|Contact: Jenny Chambers 0208 3835285|
|Principal Investigator:||Catherine Williamson, MBChBMDFRCP||Imperial College London|