Cardiovascular Diseases Clinical Trial
— EMKISCAOfficial title:
Endocrine, Metabolic, Cardiovascular and Immunological Aspects of Sex Chromosome
NCT number | NCT05425953 |
Other study ID # | EMKI SCA |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 13, 2022 |
Est. completion date | May 1, 2025 |
Observational study of 160 patients with sex-chromosome abnormalities and 160 matched controls. Blood, fat, muscle, skin, buccal swaps, urine will be collected and analyzed for DNA, RNA and methylation patterns. The goal is to associated genotype and epigenetic changes with the phenotype of patients with sex-chromosome abnormalities. Patients participate in questionaries, dexa-scan of bones, fibroscan of liver, ultra sound of testicles and blood will be analyzed for organ specific blood work as well as immunological and coagulation components.
Status | Recruiting |
Enrollment | 320 |
Est. completion date | May 1, 2025 |
Est. primary completion date | May 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Participants must have the sex-chromosome abnormality Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus university hospital | Aarhus | Region Midt |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Aarhus University Hospital |
Denmark,
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de Vos WM, Tilg H, Van Hul M, Cani PD. Gut microbiome and health: mechanistic insights. Gut. 2022 May;71(5):1020-1032. doi: 10.1136/gutjnl-2021-326789. Epub 2022 Feb 1. — View Citation
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Gravholt CH, Poulsen HE, Ott P, Christiansen JS, Vilstrup H. Quantitative liver functions in Turner syndrome with and without hormone replacement therapy. Eur J Endocrinol. 2007 Jun;156(6):679-86. doi: 10.1530/EJE-07-0070. — View Citation
Org E, Mehrabian M, Parks BW, Shipkova P, Liu X, Drake TA, Lusis AJ. Sex differences and hormonal effects on gut microbiota composition in mice. Gut Microbes. 2016 Jul 3;7(4):313-322. doi: 10.1080/19490976.2016.1203502. Epub 2016 Jun 29. — View Citation
Roulot D, Degott C, Chazouilleres O, Oberti F, Cales P, Carbonell N, Benferhat S, Bresson-Hadni S, Valla D. Vascular involvement of the liver in Turner's syndrome. Hepatology. 2004 Jan;39(1):239-47. doi: 10.1002/hep.20026. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Epigenetic changes relate to phenotype | Epigenetic changes relate to phenotype | 2½ years | |
Secondary | Immunologic changes in turner syndrom | Patients with Turner syndrome may have altered immunological properties | 2 years |
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