An observational study in Klinefelter Syndrome, 47,XXY and Sex Chromosome Aneuploidy, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to male participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-03-08.
Sponsored by University of Colorado, Denver · Observational
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Among 18 studies in Klinefelter Syndrome with a site in United States — 3 open to participants now, 4 under way, none of them phase 3. Klinefelter Syndrome · United States.
Among the 18 studies in Klinefelter Syndrome with a site in United States, this one is the 8th largest by enrollment of the 10 observational ones that give a count, is one of 2 that started in 2016, is one of 10 observational ones, and was the 12th registered.
47 studies on the registry are indexed under Klinefelter Syndrome; 17 are open to participants now.
Browse Klinefelter Syndrome studies →3 of the 18 studies in Klinefelter Syndrome with a site in United States are open now. Recruiting first, the newest first:
University of Colorado, Denver · Sites in United States
Ages 0 days–100 yrs · Healthy volunteers
University of Colorado, Denver · Sites in United States
Ages 6 wk–13 mo
RTI International · Sites in United States
Ages up to 99 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 11 Klinefelter Syndrome studies recruiting now, 2 (18%) set no upper age limit and 5 (45%) stop at 75 or younger; 7 take children under 18; 2 take healthy volunteers.
This study: 12 Years to 17 Years · male · no healthy volunteers.
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18 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 31 is below the median of 300 across 27 observational studies indexed under Klinefelter Syndrome.
Median enrollment 46 across the 8 interventional studies, 301 across the 10 observational. Of the 11 that completed or were terminated, 4 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 18 have an industry lead sponsor. The 10 most frequent:
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
University of Colorado, Denver has 7 studies filed under Klinefelter Syndrome — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 18 studies in Klinefelter Syndrome with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
The study will enroll 10 youth with 47,XXY who will be subdivided into 2 groups:
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Exclusion Criteria:
Boys with Klinefelter syndrome age 12-17 who are Tanner 3, 4, or 5. No exogenous testosterone exposure in the past 5 years
Other: No intervention
Boys with Klinefelter syndrome age 12-17 who are Tanner 3, 4, or 5. +topical testosterone treatment for \>1 year
Other: No intervention
VO2 peak
The primary outcome will be peak oxygen consumption (VO2 peak) during exercise on a bicycle ergometer
Time frame: baseline
Body composition
Percent body fat by dual-energy x-ray absorptiometry
Time frame: baseline
Liver fat
Intrahepatic fat by abdominal magnetic resonance imaging
Time frame: baseline
Muscle mitochondrial metabolism
Rate of mitochondrial phosphorylation by 31-phosphorus magnetic resonance spectroscopy of the calf muscles
Time frame: baseline
Insulin sensitivity
oral disposition index with Glucola
Time frame: baseline
Plan to share: No
The record gives a start of May 2016, a primary completion of Dec 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver →