Impact of Hormone Therapy on Blood Sugar in Transgender Individuals
Effect of Gender Affirming Hormone Therapy on Glucose Metabolism
This study is testing how hormone therapy affects blood sugar levels in transgender individuals to see if estrogen helps transwomen and if testosterone affects transmen differently.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT04515472 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of gender-affirming hormone therapy on glucose metabolism in transgender individuals. It aims to determine if estrogen treatment in transwomen improves insulin sensitivity and beta cell function, while assessing if testosterone treatment in transmen negatively impacts these parameters. Participants will undergo a two-hour oral glucose tolerance test and a DXA scan to estimate lean body mass, with follow-up tests conducted after discontinuation of hormone therapy. The study will also evaluate the relationship between sex hormones and beta cell function through various measurements.
Who should consider this trial
Good fit: Ideal candidates include healthy transgender individuals who have been on stable hormone treatment for at least six months and are non-diabetic.
Not a fit: Patients with a history of diabetes or recent cardiovascular events may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of glucose metabolism in transgender individuals undergoing hormone therapy.
How similar studies have performed: While there is limited research specifically on this topic, similar studies have shown promising results regarding hormone therapy's effects on metabolic health.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy volunteers: healthy male or female * MTF transgender * FTM transgender * Non-diabetic (A1c\<6.5%), fasting glucose \<126mg/dl and OGTT after 2 hr \<200mg/dl) * Stable hormone treatment (estrogen or testosterone) for at least 6 months Exclusion Criteria: * History of or newly diagnosed diabetes mellitus * For healthy volunteers, not current treatment with estrogen or testosterone * For FTM transgender, no recent cardiovascular event: acute coronary syndrome (ACS), stroke (CVA) * For MTF and FTM transgender, less than 6 months of stable hormone treatment * Anemia with hemoglobin (Hb) \<11.0 hematocrit (Hto) \< 34 and Glomerular Filtration rate (GFR) \<30
Where this trial is running
San Antonio, Texas
- Bartter Clinical Research Unit, Audie L. Murphy VA Hospital, sTXVHCS — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Devjit Tripathy, MD — University of Texas Health San Antonio
- Study coordinator: Devjit Tripathy, MD
- Email: tripathy@uthscsa.edu
- Phone: 210-617-5300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.