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Search / Trial NCT06733415

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

Launched by TEL-AVIV SOURASKY MEDICAL CENTER · Dec 10, 2024

Trial Information

Current as of November 11, 2025

Enrolling by invitation

Keywords

Trangender, Metabolic Rate

ClinConnect Summary

This is a small, forward-looking study to understand how a person’s daily energy use changes around gender-affirming hormone therapy. The main idea is to measure resting metabolic rate (the calories your body burns while at rest) before starting hormones and then again after several months of treatment. Researchers will also track changes in weight, body fat and muscle, waist size, blood pressure, and routine blood tests (including hormones, blood sugar, and cholesterol). They’ll also look at gut bacteria and overall daily activity. A special testing room will be used to measure energy use, and participants will wear a activity tracker for about a week.

If you’re eligible, you could join this observational study as a transgender person (trans women or trans men) who is 17 years or older, has not had hormone therapy in the past year, and has had a stable weight in the last six months. Exclusion criteria include pregnancy, certain medical conditions, or medications that affect metabolism. If you join, you’ll have visits at baseline, around 3 months, and around 6 months after starting hormone therapy, with overnight fasting blood tests, measurements of height, weight, body composition, and blood pressure, plus the energy-use test and the stool sample. The study is conducted at Tel Aviv Sourasky Medical Center in Israel and is offered by invitation, aiming to enroll roughly 20–40 participants.

Gender

ALL

Eligibility criteria

  • 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

About Tel Aviv Sourasky Medical Center

Tel Aviv Sourasky Medical Center, a leading academic medical institution in Israel, is renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a multidisciplinary approach, the center integrates cutting-edge medical technology and evidence-based practices to enhance patient care and outcomes. Its robust infrastructure supports a diverse range of clinical studies, fostering collaboration among healthcare professionals, researchers, and industry partners. The center's dedication to research excellence and patient safety positions it as a key player in the global clinical research landscape, driving advancements in medical knowledge and treatment options.

Locations

Tel Aviv Yafo, Israel

Patients applied

0 patients applied

Trial Officials

Yael Sofer, MD

Principal Investigator

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported