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Effect of Gender Affirming Hormone Therapy on Glucose Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04515472
Recruitment Status : Recruiting
First Posted : August 17, 2020
Last Update Posted : January 20, 2022
Sponsor:
Collaborator:
Foundation for advancing Veterans Health Research (FAVHR)
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date  ICMJE August 13, 2020
First Posted Date  ICMJE August 17, 2020
Last Update Posted Date January 20, 2022
Actual Study Start Date  ICMJE June 17, 2020
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2020)
  • Effects of Chronic estrogen therapy on insulin secretion [ Time Frame: Baseline to 180 minutes ]
    Change in GLP-1 in response to glucose
  • Effects of Chronic estrogen therapy on insulin sensitivity [ Time Frame: Baseline to 6 months ]
    Change in beta cell function
  • Effects of Chronic testosterone therapy on insulin secretion [ Time Frame: Baseline to 180 minutes ]
    Change in GLP-1 in response to glucose
  • Effects of Chronic testosterone therapy on insulin sensitivity [ Time Frame: Baseline to 6 months ]
    Change in beta cell function
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2020)
Immune response change [ Time Frame: Baseline to 6 months ]
Withhold GAHT for 2 weeks after Botnia Clamp
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Gender Affirming Hormone Therapy on Glucose Metabolism
Official Title  ICMJE Effect of Gender Affirming Hormone Therapy on Glucose Metabolism
Brief Summary

The study will test:

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

All subjects will participate in a 2-hour oral glucose tolerance test (OGTT) and DXA scan for estimation of lean body mass. Only the transgender subjects will have a repeat OGTT two weeks after discontinuation of Gender Affirming Hormone Therapy (GAHT).

Beta cell function will be correlated with the Estrogen/Testosterone ratio to evaluate the relationship between sex hormones and beta cell function. Plasma Glucagon-like peptide 1 (GLP-1) response during the OGTT will be measured to evaluate if estrogen treatment modulates insulin secretion by increasing GLP-1 secretion.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
MTF and FTM non-diabetic transsexuals will be compared to healthy female and male subjects respectively.
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Transgender Persons
Intervention  ICMJE
  • Drug: Botnia Clamp
    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.
    Other Name: Glucose solution and insulin
  • Other: Withdrawal of Gender Affirming Hormone Therapy (GAHT)
    GAHT, either estrogen or testosterone therapy will be withdrawn after the Botnia Clamp.
Study Arms  ICMJE
  • Active Comparator: Healthy Volunteer Male
    Healthy male currently on no testosterone treatment
    Intervention: Drug: Botnia Clamp
  • Active Comparator: Healthy Volunteer Female
    Healthy female currently on no estrogen treatment
    Intervention: Drug: Botnia Clamp
  • Active Comparator: MTF group
    MTF transgender currently on estrogen treatment
    Interventions:
    • Drug: Botnia Clamp
    • Other: Withdrawal of Gender Affirming Hormone Therapy (GAHT)
  • Active Comparator: FTM group
    FTM transgender group currently on testosterone treatment
    Interventions:
    • Drug: Botnia Clamp
    • Other: Withdrawal of Gender Affirming Hormone Therapy (GAHT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 13, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2024
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Devjit Tripathy, MD 210-617-5300 ext 17822 tripathy@uthscsa.edu
Contact: Emina Case 210-617-5300 ext 17822 morinae@uthscsa.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04515472
Other Study ID Numbers  ICMJE HSC20190415H
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party The University of Texas Health Science Center at San Antonio
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Foundation for advancing Veterans Health Research (FAVHR)
Investigators  ICMJE
Principal Investigator: Devjit Tripathy, MD University of Texas Health San Antonio
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP