Metabolic Consequences of Cross-sex Hormonal Treatment

• Conditions: Gender Dysphoria

• 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

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