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Clinical Trials in Israel / NCT06733415
Enrolling by invitation Observational

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

NCT06733415 · tracked via the Priya Life Science Israel tracker
Sponsor
Tel-Aviv Sourasky Medical Center
Phase
Observational
Started
2024-01-03
Last updated
2024-12-13

Condition(s) studied

TransgenderTransgender Persons, M01.777.500

Study summary

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

Eligibility

Sex
ALL
Min age
17 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1\. TW and TM with no prior hormonal therapy in the last one year. 2. Stable weight in last six months (\<±5% weight change), \- Exclusion Criteria: 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

Primary outcome measure(s)

  • RESTING METABOLIC RATE — 6-12 months
    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

Trial sites (1)

FacilityCityRegionStatus
Tel Aviv Sourasky Medical Center Tel Aviv Israel

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06733415 on ClinicalTrials.gov ↗ ← All trials in Israel