Changes in Energy Expenditure (EE) in Transsexuals Undergoing Hormonal Therapy

NCT06733415 | Enrolling By Invitation DMC

• 1 other identifier: 0697-22
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Examining Metabolic Rate in Transgender individuals before starting hormonal treatment and 6-12 months after initiation

Conditions

Transgender; Transgender Persons, M01.777.500

Keywords

trangender, metabolic rate

Outcome Measures

Primary Outcomes (1)

• RESTING METABOLIC RATE

  Methods Study design: A pilot observational prospective study, recruiting 34 transsexuals: 17 transwomen (TW) and 17 transmen (TM). Criteria for inclusion 1. TW and TM with no prior hormonal therapy in the last one year. 2. Stable weight in last six months (\<±5% weight change), Criteria for exclusion 1. Postmenopausal TM. 2. Oral contraceptive use. 3. Pregnancy or breastfeeding. 4. Glucocorticosteroid treatment 5. Uncontrolled thyroid disorders 6. Use of drugs that potentially impact body metabolism Follow up will be for 6 months. Baseline tests and after 3 and 6 months of treatment: 1\. Anthropometrics: 1. Body weight will be measured to the nearest 10 g on a digital scale (Seca, 'mBCA') after 12 hours of overnight fast. 2. Height will be measured with a wireless digital stadiometer (Seca 274) to the nearest 0.1 cm at baseline. 3. Changes in body composition, including Fat and Fat Free Mass, will be evaluated by multi-frequency bioelectrical impedance analysis (BIA) after 12 hour

  6-12 months

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Transgender individuals prior to gender affirming hormonal therapy

You may qualify if:

• \. TW and TM with no prior hormonal therapy in the last one year. 2. Stable weight in last six months (\<±5% weight change),

You may not qualify if:

• Postmenopausal TM.
• Oral contraceptive use.
• Pregnancy or breastfeeding.
• Glucocorticosteroid treatment
• Uncontrolled thyroid disorders
• Use of drugs that potentially impact body metabolism

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

CBC, cortisol, glucose, HBA1C , FULL CHEMISTRY, LIPID PANEL, LH FSH ESTRADIOL TESTOSTERONE, PROLACTIN, PROGESTERONE

Study Officials

• Yael Sofer, MD

  Department of Endocrinology, Metabolism and Hypertension, Tel Aviv Sourasky Medical Center and Tel Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: January 3, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

IL (1)