Effect of Gender Affirming Hormone Therapy on Glucose Metabolism

NCT04515472 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: HSC20190415H
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The study will test:

1. 1.whether estrogen treatment in transwomen is associated with improved insulin sensitivity and beta cell function
2. 2.whether testosterone treatment in transmen is associated with worsening insulin sensitivity and beta cell function
3. 3.whether estrogen therapy leads to enhanced immune response in older transwormen

Conditions

Transgender Persons

Outcome Measures

Primary Outcomes (4)

• Effects of Chronic estrogen therapy on insulin secretion

  Change in GLP-1 in response to glucose

  Baseline to 180 minutes

• Effects of Chronic estrogen therapy on insulin sensitivity

  Change in beta cell function

  Baseline to 6 months

• Effects of Chronic testosterone therapy on insulin secretion

  Change in GLP-1 in response to glucose

  Baseline to 180 minutes

• Effects of Chronic testosterone therapy on insulin sensitivity

  Change in beta cell function

  Baseline to 6 months

Secondary Outcomes (1)

• Immune response change

  Baseline to 6 months

Study Arms (4)

Healthy Volunteer Male

ACTIVE COMPARATOR

Healthy male currently on no testosterone treatment

Drug: Botnia Clamp

Healthy Volunteer Female

ACTIVE COMPARATOR

Healthy female currently on no estrogen treatment

Drug: Botnia Clamp

MTF group

ACTIVE COMPARATOR

MTF transgender currently on estrogen treatment

Drug: Botnia Clamp; Other: Withdrawal of Gender Affirming Hormone Therapy (GAHT)

FTM group

ACTIVE COMPARATOR

FTM transgender group currently on testosterone treatment

Drug: Botnia Clamp; Other: Withdrawal of Gender Affirming Hormone Therapy (GAHT)

Interventions

Botnia Clamp DRUG

This clamp technique is designed to obtain independent measures of insulin secretion and insulin sensitivity during the same test. In brief, 0.3g/kg body wt of a 20% glucose solution is given at time 0. Blood samples for the measurement of plasma glucose and serum insulin are obtained at -10, 0, 2, 4, 6, 8, 10, 20, 30, 40, 50, 60, 120, and 180 min.

Also known as: Glucose solution and insulin

FTM group; Healthy Volunteer Female; Healthy Volunteer Male; MTF group

Withdrawal of Gender Affirming Hormone Therapy (GAHT) OTHER

GAHT, either estrogen or testosterone therapy will be withdrawn after the Botnia Clamp.

FTM group; MTF group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Foundation for Advancing Veterans' Health Research: collaborator

Study Sites (1)

Bartter Clinical Research Unit, Audie L. Murphy VA Hospital, sTXVHCS

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

Insulin

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Devjit Tripathy, MD

  University of Texas Health San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: MTF and FTM non-diabetic transsexuals will be compared to healthy female and male subjects respectively.

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 17, 2020
• Study Start: June 17, 2020
• Primary Completion: March 17, 2025
• Study Completion: March 17, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

US (1)