The Metabolic Profile in Intrahepatic Cholestasis of Pregnancy and Diabetes Mellitus

NCT01499524 | Completed

• 1 other identifier: JROHH0280
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

ICP, GDM

Outcome Measures

Primary Outcomes (1)

• To establish whether raised serum bile acids are associated with abnormalities in cholesterol and triglycerides in the mother and fetus mother and fetus.

  Maternal serum samples from women with ICP and controls will be collected to measure cholesterol and triglycerides

  5 years

Secondary Outcomes (1)

• 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, glucose and C4 levels, Gut hormone secretion

  5 years

Eligibility Criteria

• Age: 16 Years - 70 Years
• Gender Eligibility Details: women age 16-70
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (2)

Guy's & St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Imperial College Healthcare NHS Trust Hammersmith

London, United Kingdom

Location

Related Publications (1)

• Mitchell AL, Ovadia C, Syngelaki A, Souretis K, Martineau M, Girling J, Vasavan T, Fan HM, Seed PT, Chambers J, Walters J, Nicolaides K, Williamson C. Re-evaluating diagnostic thresholds for intrahepatic cholestasis of pregnancy: case-control and cohort study. BJOG. 2021 Sep;128(10):1635-1644. doi: 10.1111/1471-0528.16669. Epub 2021 Apr 6.

  PMID: 33586324 RESULT

Related Links

• Re-evaluating diagnostic thresholds for intrahepatic cholestasis of pregnancy: case-control and cohort study

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, whole blood, plasma.

MeSH Terms

Conditions

Intrahepatic Cholestasis of Pregnancy; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Catherine Williamson, MBChBMDFRCP

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: December 26, 2011
• Study Start: November 1, 2011
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)