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Paternally Inherited Phenotypes in Cholestasis

NCT03337074 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2019-08-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • King's College Hospital NHS Trust

    collaborator OTHER

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-08
Primary Completion
2020-04-30
Completion
2020-04-30

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 NCT03337074 on ClinicalTrials.gov