Metabolic Consequences of Cross-sex Hormonal Treatment (DysGeMet)

Metabolic Consequences of Cross-sex Hormonal Treatment in Transgender Persons

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

Study Overview

• Status: Unknown
• Conditions: Gender Dysphoria
• Intervention / Treatment: Other: Gender-affirming hormone therapy

• Study Type: Observational
• Enrollment (Anticipated): 98

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54000
    • Chru Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Gender-affirming hormone therapy according to the recommendations of the Endocrine Society
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 24, 2020
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (ACTUAL): August 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Gender Dysphoria; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: 2020PI157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No