Cardiometabolic Profiles of Boys With Klinefelter Syndrome
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Other Indications, Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 12 - 17 |
| Updated: | 2/1/2019 |
| Start Date: | May 2016 |
| End Date: | December 2019 |
Cardiometabolic Profiles of Pubertal Boys With Klinefelter Syndrome With or Without One Year of Exogenous Testosterone Treatment
This study plans to learn more about how to measure the way the the body's energy system
works in boys with Klinefelter syndrome, including the heart, lungs, muscles, and liver. This
is important to know so that investigators understand how hormones and an extra X chromosome
relate to diseases such as diabetes, extra weight gain, heart disease and liver diseases.
works in boys with Klinefelter syndrome, including the heart, lungs, muscles, and liver. This
is important to know so that investigators understand how hormones and an extra X chromosome
relate to diseases such as diabetes, extra weight gain, heart disease and liver diseases.
Klinefelter syndrome (KS) is the most common chromosomal abnormality in males and is
associated with primary gonadal failure in adolescence and a high morbidity and mortality
from cardiovascular-related diseases (CVD) in adulthood. Recent studies in children and
adolescent boys with KS have found a high prevalence of CVD risk markers, however the
underlying mechanisms have not been explored. Our central hypothesis is that pubertal boys
with KS have relative testosterone deficiency resulting in abnormal energy metabolism that
predisposes them to later CVD, and that exogenous testosterone will modify these
abnormalities.
In this study, investigators will measure markers of cardiometabolic risk in pubertal boys
with KS.
associated with primary gonadal failure in adolescence and a high morbidity and mortality
from cardiovascular-related diseases (CVD) in adulthood. Recent studies in children and
adolescent boys with KS have found a high prevalence of CVD risk markers, however the
underlying mechanisms have not been explored. Our central hypothesis is that pubertal boys
with KS have relative testosterone deficiency resulting in abnormal energy metabolism that
predisposes them to later CVD, and that exogenous testosterone will modify these
abnormalities.
In this study, investigators will measure markers of cardiometabolic risk in pubertal boys
with KS.
Inclusion Criteria:
- Male, 47,XXY karyotype (non-mosaic)
- Age 12-17 years
- Tanner stage 3-5 pubic hair
- T naïve group only: No exogenous androgen exposure within the past 5 years
- T exposed group only: currently on topical testosterone, with duration of treatment
between 1-2 years.
Exclusion Criteria:
- Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the
study procedures
- MRI incompatible metal
- Diagnosis of type 1 or type 2 diabetes
- Hypertension greater than 140/90 mm/Hg at rest (would make exercise studies unsafe)
- Weight > 300 lbs (limit for DEXA)
- Testosterone treatment for <1 year or >2 years
We found this trial at
1
site
13123 E 16th Ave
Aurora, Colorado 80045
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Shanlee M Davis, MD
Phone: 720-777-6073
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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