NCT03337074

Paternally Inherited Phenotypes in Cholestasis

Investigation of the Effect of Raised Serum Bile Acids on the Epigenome of Sperm and the Association With the Metabolic Health of the Children of Men With Cholestasis: a Case-control Study.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

For some years investigators have known that the health of fathers at the time their baby is conceived has an influence on the health of their child in the future. Many studies looking at this effect have investigated fathers with obesity and other metabolic disorders. These disorders can alter the risk of obesity and diabetes in the children of these men. More recently, studies have been undertaken to establish the mechanism by which this risk is inherited by the children. Studies of sperm have identified that changes in the structure and function of the sperm play a role. Primary Sclerosing Cholangitis (PSC) and Primary Biliary Cholangitis (PBC) are included in a group of cholestatic liver disorders that are associated with elevated levels of bile acids in the blood (cholestasis). A previous study has established that children born to women who have cholestasis during pregnancy are at an increased risk of obesity later in life. Our study will investigate whether there is a similar effect on the health of children if their father has cholestasis. The study has 2 arms, the Sperm Epigenome arm and the Outcomes arm. In the Sperm Epigenome arm of the study, the structure and function of sperm from men with PSC, PBC and other cholestatic liver disorders will be investigated and compared to the structure and function of sperm from healthy men. In the Outcomes arm of the study, basic health parameters of fathers who had PSC, PBC or another cholestatic liver disease either before or after their child was conceived will be studied. Basic health parameters will also be studied in their child when the child is between 16 and 25 years of age.

Conditions

• Cholestasis
• Primary Sclerosing Cholangitis
• Primary Biliary Cirrhosis

Interventions

Type	Name	Description
OTHER	Questionnaire, semen sample, fasting blood sample	Participants are asked to complete a questionnaire and provide a semen sample and fasting blood sample.
OTHER	Questionnaire	Participants are asked to complete a questionnaire.
OTHER	Questionnaire, fasting blood sample	Participants are asked to complete a questionnaire and provide a fasting blood sample.

Timeline

• Start date: 2017-02-08
• Primary completion: 2020-04-30
• Completion: 2020-04-30
• First posted: 2017-11-08
• Last updated: 2019-08-02

Locations

2 sites across 1 country: United Kingdom