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Effect of Gender Affirming Hormone Therapy on Glucose Metabolism

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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Transgender Persons Drug: Botnia Clamp Other: Withdrawal of Gender Affirming Hormone Therapy (GAHT) Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Official Title: Effect of Gender Affirming Hormone Therapy on Glucose Metabolism
Actual Study Start Date : June 17, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
Drug Information available for: Dextrose

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Healthy Volunteer Male
Healthy male currently on no testosterone treatment
 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
Active Comparator: Healthy Volunteer Female
Healthy female currently on no estrogen treatment
 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
Active Comparator: MTF group
MTF transgender currently on estrogen treatment
 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.
Active Comparator: FTM group
FTM transgender group currently on testosterone treatment
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Effects of Chronic estrogen therapy on insulin secretion [ Time Frame: Baseline to 180 minutes ]
    Change in GLP-1 in response to glucose

  2. Effects of Chronic estrogen therapy on insulin sensitivity [ Time Frame: Baseline to 6 months ]
    Change in beta cell function

  3. Effects of Chronic testosterone therapy on insulin secretion [ Time Frame: Baseline to 180 minutes ]
    Change in GLP-1 in response to glucose

  4. Effects of Chronic testosterone therapy on insulin sensitivity [ Time Frame: Baseline to 6 months ]
    Change in beta cell function


Secondary Outcome Measures :
  1. Immune response change [ Time Frame: Baseline to 6 months ]
    Withhold GAHT for 2 weeks after Botnia Clamp


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04515472


Contacts
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Contact: Devjit Tripathy, MD 210-617-5300 ext 17822 tripathy@uthscsa.edu
Contact: Emina Case 210-617-5300 ext 17822 morinae@uthscsa.edu

Locations
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United States, Texas
Bartter Clinical Research Unit, Audie L. Murphy VA Hospital, sTXVHCS Recruiting
San Antonio, Texas, United States, 78229
Contact: Devjit Tripathy, MD    210-617-5300 ext 17822    tripathy@uthscsa.edu   
Contact: Emina Case    210-617-5300 ext 17822    morinae@uthscsa.edu   
Principal Investigator: Devjit Tripathy, MD         
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Foundation for advancing Veterans Health Research (FAVHR)
Investigators
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Principal Investigator: Devjit Tripathy, MD University of Texas Health San Antonio
More Information
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT04515472    
Other Study ID Numbers: HSC20190415H
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: January 20, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hormones
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists