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The Metabolic Profile in Intrahepatic Cholestasis of Pregnancy and Diabetes Mellitus

NCT01499524 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 116

Last updated 2025-04-03

No results posted yet for this study

Summary

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.

Conditions

  • Intrahepatic Cholestasis of Pregnancy
  • Gestational Diabetes Mellitus

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Catherine Williamson, MBChBMDFRCP · Imperial College London

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2023-04-30
Completion
2023-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01499524 on ClinicalTrials.gov