Metabolic Consequences of Cross-sex Hormonal Treatment

• Conditions: Gender Dysphoria
• Interventions: Other: Gender-affirming hormone therapy

• Registration Number: NCT04508231
• Lead Sponsor: Central Hospital, Nancy, France

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study Start: 2020-07-24
• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-07
• Last Update Submitted: 2020-08-07
• Study First Posted: 2020-08-11
• Last Update Posted: 2020-08-11
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hormonal treatment	Gender-affirming hormone therapy	The University Hospital in Nancy is an academic regional transgender referral center in Lorraine (France) and keeps a register of subjects available from 2004. The register at the time of the present study (February 2020) included 320 subjects who met diagnostic criteria for gender dysphoria and were seen regularly in the out-patient clinic at our department of endocrinology. Our investigation is a part of the regular care of subjects with gender dysphoria.

Primary Outcome Measures

Name	Time	Method
Retrospective analysis of existing data collected as a part of the regular follow-up	Retrospective analysis of data between 2004 and 2019	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

Trial Locations

Locations (1)

CHRU Nancy; 🇫🇷 Nancy, France