Metabolic Consequences of Cross-sex Hormonal Treatment

Gender Dysphoria Clinical Trial

— DysGeMet  

Official title:

Metabolic Consequences of Cross-sex Hormonal Treatment in Transgender Persons

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04508231
• Other study ID #: 2020PI157
• Status: Active, not recruiting
• Start date: July 24, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: July 2020
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Retrospective study in a single academic regional transgender referral center. Analyse VAT, body composition and metabolic parameters in non-obese transgender subjects one year after starting gender-affirming hormone therapy and in controls

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 98
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (retrospective analysis of available data as a part of the regular care of subjects with gender dysphoria. All measurements were made at the time of the routine follow-up visits)

• age >= 16 years (Tanner stage IV) and <= 50 years at the initiation of gender-affirming hormone therapy;

• BMI < 28 kg/m2 at the initiation of cross-sex hormonal treatment.

Exclusion Criteria:

• hormonal contraception

• previous gender-affirming hormonal treatment

• previous gender-affirming surgery

• recognized syndrome or chromosomal defect, known metabolic or inflammatory disease, skeletal dysplasia, or chronic corticosteroid treatment.

Related Conditions & MeSH terms

• Gender Dysphoria

Intervention

Other:
• Gender-affirming hormone therapy
Gender-affirming hormone therapy according to the recommendations of the Endocrine Society

Locations

Country	Name	City	State
France	CHRU Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retrospective analysis of existing data collected as a part of the regular follow-up	Retrospective analysis of existing data :Anthropometric parameters, including systolic blood pressure (SBP), diastolic blood pressure (DBP), body weight and height at fasting state, were measured in all subjects at the occasion of the routine follow-up visits. Body mass index (BMI) was calculated as body weight in kilograms divided by the height in meter squared (kg/m2). Body composition parameters, including lean mass (LM), total body fat (BF), android and gynoid fat, and bone mineral content, were determined using dual-energy X-Ray absorbtiometry (DXA) (GE-Healthcare Lunar iDXA system), biochemical and routine hormonal analysis	Retrospective analysis of data between 2004 and 2019