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The physical and psychological effects of the hormonal treatment of transsexual persons are not sufficiently described. 'Transparency' wants to answer this question in a prospective manner, in a multicenter study to describe these effects. The low prevalence of transsexualism was the stimulus to search for European partners for this Protocol. A common standardized hormonal protocol was designed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transgender people starting hormone treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaires | Other | a descriptive questionnaire, SF-36, , bone questionnaires, Baecke physical activity questionnaire, voice evaluation |
|
| Measure | Description | Time Frame |
|---|---|---|
| physical and psychological effects of the hormonal treatment of transsexual persons | evaluations will be done every 3 months the first year of therapy, every 6 months in the second year, and after sex reassignment surgery annually. | annually |
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Inclusion Criteria:
Exclusion Criteria:
-
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transsexual persons older than 18 years, who are not yet treated with hormonal therapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guy T'Sjoen, MD | Contact | guy.tsjoen@ugent.be |
| Name | Affiliation | Role |
|---|---|---|
| Guy T'Sjoen, MD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genderteam UZ Gent | Recruiting | Ghent | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31740479 | Derived | Shadid S, Abosi-Appeadu K, De Maertelaere AS, Defreyne J, Veldeman L, Holst JJ, Lapauw B, Vilsboll T, T'Sjoen G. Effects of Gender-Affirming Hormone Therapy on Insulin Sensitivity and Incretin Responses in Transgender People. Diabetes Care. 2020 Feb;43(2):411-417. doi: 10.2337/dc19-1061. Epub 2019 Nov 18. | |
| 29216353 | Derived |
| Label | URL |
|---|---|
| website of the University Hospital of Ghent | View source |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| blood sampling | Biological | LFT (AST, ALT), CRP, creatinine, glucose, Total Cholesterol, Triglycerides, HDL-CH, LDL-CH, 25OH vitamin D, PSA if> 45 years, Hematocrit, testosterone, sex hormone-binding globulin, free testosterone , oestradiol, prolactin, luteinizing hormone, TSH, androgeengevoeligheids test (CAG RL), oral glucose tolerance test |
|
| clinical evaluation | Other | height, weight, blood pressure, chestcircumference, waist circumference, grip strength, measuring 2 ° and 4 ° finger, and Ferriman Gallwey score |
|
| Dermatology evaluation | Other | Evaluation of the hair pattern, using the Leeds acne classification scale, acne scars through ECCA scale (échelle d'évaluation clinique des cicatrices d'acné), androgenetic alopecia, and sebummetrie |
|
| Bone evaluation | Other | PQCT scanner, BMD assessment |
|
| Recruiting | Florence | Italy |
|
| VU University Medical CenterAmsterdam | Recruiting | Amsterdam | Netherlands |
|
| Rikshospitalet University Hospital, University of Oslo | Recruiting | Oslo | Norway |
|
| Auer MK, Ebert T, Pietzner M, Defreyne J, Fuss J, Stalla GK, T'Sjoen G. Effects of Sex Hormone Treatment on the Metabolic Syndrome in Transgender Individuals: Focus on Metabolic Cytokines. J Clin Endocrinol Metab. 2018 Feb 1;103(2):790-802. doi: 10.1210/jc.2017-01559. |
| 28730692 | Derived | Bultynck C, Pas C, Defreyne J, Cosyns M, den Heijer M, T'Sjoen G. Self-perception of voice in transgender persons during cross-sex hormone therapy. Laryngoscope. 2017 Dec;127(12):2796-2804. doi: 10.1002/lary.26716. Epub 2017 Jul 21. |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |