Puberty Suppression and Cardiometabolic Health | NCT04482374

Studies
Puberty Suppression and Cardiometabolic Health

NCT04482374

Sponsor

University of Colorado, Denver

Status

Recruiting

Last Update Posted

Jun 10, 2025Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Transgenderism
Insulin Sensitivity/Resistance
Endothelial Dysfunction
Vascular Stiffness

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 10, 2020Actual

Primary Completion Date

Jul 31, 2026Estimated

Completion Date

Jul 31, 2026Estimated

First Submitted Date

Jun 30, 2020

First Submission Date that Met QC Criteria

Jul 17, 2020

First Posted Date

Jul 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2025

Last Update Posted Date

Jun 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This observational study will evaluate the effect of puberty suppression on insulin sensitivity, metabolic rate and vascular health among transgender female youth at baseline and 6 months after initiation of a gondoatropin releasing hormone agonist compared to matched cisgender male controls.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transgender females		Transgender females who plan to start a gonadotropin releasing hormone agonist clinically in the next 2 months
Cisgender males		Cisgender male controls

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in insulin sensitivity	Insulin sensitivity assessed by the oral minimal model	Baseline, 6 months

Secondary Outcomes

Measure	Description	Time Frame
Change in body composition (fat mass, fat-free mass)	Body composition measured by DXA	Baseline, 6 months
Change in resting metabolic rate	Resting metabolic rate assessed by indirect calorimetry

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Identify as a transgender female or cisgender male
Age 9-14 years at the time of enrollment
Tanner Stage 2-3 baseline pubertal development
Plan to start gonadotropin releasing hormone analogue clinically in < 2 months (for transgender females only)

Exclusion Criteria:

Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures
Type 1 or 2 diabetes (by medical history)
On any medications that affect insulin sensitivity (e.g. metformin, antipsychotics)
Hypertension (resting BP ≥ 140/90 mm/Hg)
Weight > 400 lbs
On estrogen- or progesterone-containing medications at baseline
>3 hours of moderate-to-vigorous physical activity on the 3DPAR at the screening visit

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Transgender females, cisgender males

Minimum Age

9 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

15 transgender females (male sex assigned at birth, female gender identity) and 15 cisgender males

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Natalie J Nokoff, MD, MSCS	Contact	720-777-6128		natalie.nokoff@childrenscolorado.org

Overall Officials

Name	Affiliation	Role
Natalie J Nokoff, MD, MSCS	University of Colorado, Denver	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado Anschutz Medical Campus	Recruiting	Aurora	Colorado	80045	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014189	Transsexualism
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D019529	Sexuality
D012725	Sexual Behavior
D001519	Behavior
D006946	Hyperinsulinism

Browse Leaves

Not provided

Browse Branches

Not provided