Metabolic Consequences of Cross-sex Hormonal Treatment

NCT04508231 | Unknown

• 1 other identifier: 2020PI157
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

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

Conditions

Gender Dysphoria

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Hormonal treatment

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.

Other: Gender-affirming hormone therapy

Controls

Data for control subjects are retrieved from medical records of healthy non-obese females and males who underwent an initial assessment for gender dysphoria in our department, but not yet receiving hormonal treatment at the time of the present study.

Interventions

Gender-affirming hormone therapy OTHER

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

Hormonal treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Subjects who met diagnostic criteria for gender dysphoria (International Classification of Diseases 11th Revision. https://icdwhoint. 2018) and were seen regularly in the out-patient clinic at our department of endocrinology
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects who met diagnostic criteria for gender dysphoria (International Classification of Diseases 11th Revision. https://icdwhoint. 2018) and were seen regularly in the out-patient clinic at our department of endocrinology

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Nancy, 54000, France

Location

Related Publications (1)

• Larose C, Samhani C, Consolandi P, Feigerlova E. Increase in visceral adipose tissue and altered metabolic profile in transgender men but not in transgender women one year after starting gender-affirming hormonal therapy. Endocrine. 2025 Sep;89(3):901-909. doi: 10.1007/s12020-025-04310-y. Epub 2025 Jun 10.

  PMID: 40495044 DERIVED

MeSH Terms

Conditions

Gender Dysphoria

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 11, 2020
• Study Start: July 24, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 11, 2020

Record last verified: 2020-07

Locations

FR (1)