The Metabolic Profile of Obstetric Cholestasis - Full Text View

Purpose

Obstetric cholestasis (OC) is a liver disorder of pregnancy characterised by liver impairment and raised bile acid levels in the blood. The purpose of the study is to establish whether women with OC also have abnormalities in their metabolism that result in abnormal levels of glucose and lipids (e.g. cholesterol. The investigators will also study hormones that affect appetite as they have been shown to play a role in related disorders of the liver. The participants will include OC cases, women who have a normal pregnancy and also non-pregnant women (some of whom will have had OC in the past). This work will allow the investigators to establish whether OC is simply a disease that affects the liver and bile, or whether it also influences cholesterol/glucose metabolism and therefore may predispose affected women to other diseases, e.g. diabetes, in later life.

Condition	Phase
Cholestasis of Pregnancy	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 Patients With Obstetric Cholestasis and Normal Pregnant and Nonpregnant Controls

Resource links provided by NLM:

Genetics Home Reference related topics: intrahepatic cholestasis of pregnancy progressive familial intrahepatic cholestasis

MedlinePlus related topics: Cholesterol

U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:

That raised serum bile acids are associated with abnormalities in cholesterol and triglycerides in the mother and fetus. [ Time Frame: Five years ] [ Designated as safety issue: No ]
To establish the incidence of dyslipidaemia (alterations in the serum concentrations of total cholesterol, cholesterol subclasses and fasting triglycerides) in relation to elevated serum bile acids in pregnancies (as seen in Obstetric Cholestasis)

Secondary Outcome Measures:

The relationship between raised serum bile acids in the mother and fetus and abnormalities in glucose homeostasis. [ Time Frame: Five years ] [ Designated as safety issue: No ]
To establish the relationship between elevated bile acids in pregnancy (as seen in Obstetric Cholestasis) and the incidence of impaired fasting glycemia and impaired glucose tolerance. To do this the serum bile acid level will be measured, and if raised >14umol/L we will investigate whether the raised serum bile acids are associated with raised plasma glucose levels in the mother or in the fetal umbilical cord blood at delivery.
The relationship between raised serum bile acids in the mother and fetus and abnormalities in gut liver signalling hormones related to FGF 19 and C4 levels [ Time Frame: 5 years ] [ Designated as safety issue: No ]
To assess the effect of elevated maternal serum bile acids (in Obstetric cholestasis acids) on serum concentrations of intestinal FGF 19, hepatic C4 and the fetus. To do this the serum bile acid level will be measured, and if raised >14umol/L we will investigate whether the raised serum bile acids are associated with reduced plasma FGF19 or raised C4 levels in the mother or in the fetal umbilical cord blood at delivery.
The relationship between raised serum bile acids in the mother and fetus and abnormalities in gut hormone secretion [ Time Frame: 5 years ] [ Designated as safety issue: No ]
To assess for alterations in plasma gut hormone concentrations (Glucagon-like peptide-1) and elevated bile acids, as seen in pregnancies complicated by Obstetric Cholestasis. To do this the serum bile acid level will be measured, and if raised >14umol/L we will investigate whether the raised serum bile acids are associated with raised plasma GLP-1 levels in the mother.

Biospecimen Retention: Samples Without DNA

Serum, whole blood, plasma.

Estimated Enrollment:	80
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)

Eligibility

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 obstetrioc cholestasis matched with parous women who have had uncomplicated pregnancies

Criteria

Inclusion Criteria:

Cases

Women with obstetric cholestasis defined as pruritus in pregnancy in association with raised serum bile acids and in the absence of an alternative cause.
Non-pregnant parous females with previous OC.
Women who are able to give consent.
Women > 16 and < 70 years of age.

Controls

Pregnant women not affected by OC.
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, 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, diabetes mellitus
Women who are not able to give consent.
Women < 16 and > 70 years of age.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499524

Contacts

Contact: Marcus Martineau, MBBS MRCP	0207 594 2172	m.martineau@imperial.ac.uk
Contact: Jenny Chambers, B/Phil	0208 383 5285	jenny.chambers@imperial.ac.uk

Locations

United Kingdom
Imperial College Healthcare NHS Trust Hammersmith	Recruiting
London, United Kingdom
Contact: Jenny Chambers 0208 3835285

Sponsors and Collaborators

Imperial College London

Investigators

Principal Investigator:

Catherine Williamson, MBChBMDFRCP

Imperial College London

More Information

No publications provided

Responsible Party:	Imperial College London
ClinicalTrials.gov Identifier:	NCT01499524 History of Changes
Other Study ID Numbers:	JROHH0280
Study First Received:	September 26, 2011
Last Updated:	September 12, 2012
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:

Obstetric cholestasis

Additional relevant MeSH terms:

Cholestasis
Cholestasis, Intrahepatic
Pregnancy Complications
Bile Duct Diseases

Biliary Tract Diseases
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on May 21, 2013