The Metabolic Profile in Intrahepatic Cholestasis of Pregnancy and Diabetes Mellitus

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Imperial College London
Information provided by (Responsible Party):
Imperial College London Identifier:
First received: September 26, 2011
Last updated: June 29, 2015
Last verified: March 2015

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.

Condition Phase
Intrahepatic Cholestasis of Pregnancy (ICP), Gestational Diabetes Mellitus (GDM)
Phase 0

Study Type: Observational
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

Resource links provided by NLM:

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 160
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)
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Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant and non pregnant women who have had intrahepatic cholestasis of pregnancy and/or gestational diabetes mellitus matched with parous women who have had uncomplicated pregnancies

Inclusion criteria:

  • Women with intrahepatic cholestasis of pregnancy, defined as pruritus in pregnancy in association with raised serum bile acids and in the absence of an alternative cause.
  • Women with gestational diabetes mellitus (GDM) according to the diagnostic criteria used at the referring centre
  • Non-pregnant parous females with previous ICP or GDM.
  • Women who are able to give consent.
  • Women >16 and <70 years of age. Controls
  • Pregnant women not affected by ICP or GDM .
  • Non-pregnant parous females with previous uncomplicated pregnancy.
  • Women who are able to give consent.
  • Women >16 and <70 years of age.

Exclusion Criteria

  • Males.
  • Non-pregnant females with other medical disorders that can cause liver impairment, abnormal lipid or glucose metabolism in pregnancy, e.g. pre-eclampsia, acute fatty liver of pregnancy, pre-existing diabetes mellitus
  • Pregnant females with a history of other medical disorders that can cause liver impairment, abnormal lipid or glucose metabolism in pregnancy, e.g. pre-eclampsia, acute fatty liver of pregnancy, pre-existing diabetes mellitus
  • Women who are not able to give consent.
  • Women <16 and >70 years of age.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01499524

Contact: Jenny Chambers 020 8383 5285

United Kingdom
Imperial College Healthcare NHS Trust Hammersmith Recruiting
London, United Kingdom
Contact: Jenny Chambers    0208 3835285      
Sponsors and Collaborators
Imperial College London
Principal Investigator: Catherine Williamson, MBChBMDFRCP Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London Identifier: NCT01499524     History of Changes
Other Study ID Numbers: JROHH0280
Study First Received: September 26, 2011
Last Updated: June 29, 2015
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:

Additional relevant MeSH terms:
Cholestasis, Intrahepatic
Diabetes Mellitus
Diabetes, Gestational
Pregnancy Complications
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Liver Diseases
Metabolic Diseases processed this record on November 30, 2015