A Study of Cardiovascular Risk Factors in Transgender Children and Youth
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-009828
Sponsor Protocol Number: 17-009828
About this study
The purpose of this study is:
- Specific Aim 1: To determine the prevalence of obesity, cardiometabolic risk factors and mental health diagnoses among transgender children and adolescents evaluated at the Mayo clinic Transgender and Intersex Specialty Care Clinic (TISCC)
- Specific Aim 2: To measure adipokines related to energy homeostasis and insulin sensitivity in transgender children and adolescents and compare with those in cisgender age and gender matched controls.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Children and adolescents with a diagnosis of gender dysphoria
- Age 5-18 years
Exclusion Criteria:
- Type 1 or 2 diabetes mellitus
- Previous (within 6-months) or current use of weight loss medication
- Previous (within 6-months) or current use of drugs associated with weight gain (e.g. steroids/anti-psychotics)
- Previous bariatric surgery
- Recent initiation (within 3-months) of anti-hypertensive or lipid medication
- Obesity associated with genetic disorder (monogenetic obesity)
Inclusion Criteria for Controls Samples:
- Patients with normal weight and simple obesity who have previously participated inclinical trials aimed at studying the effect of vitamin-D supplementation on insulin action and vitamin D levels .
Exclusion Criteria for Control Samples:
- Hepatic or Renal disorders.
- Type 1 or Type 2 diabetes mellitus.
- Ongoing use of insulin, metformin, or oral hypoglycemic medications.
- Malabsorption disorders (celiac disease, cystic fibrosis, and inflammatory bowel disease.
- Serum 25(OH) D > 100 ng/mL, and serum calcium > 10.8 mg/dL.
- Use of glucocorticoids or anti-seizure medications in the preceding 6 months, ongoing multivitamin supplementation
- Being on any hormone therapy.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Seema Kumar, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available