Clinical Trial: Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment

Brief Summary: This research study in infant males with Klinefelter syndrome (47,XXY) will learn more about body composition (muscle and fat) and male hormones and look at the effect of testosterone shots on body composition. We know that older boys and men with Klinefelter syndrome often have more fat compared to muscle than adults without Klinefelter syndrome, but we do not know if this difference is present at birth or develops over time. We will learn if body composition and motor skills are improved with testosterone treatment in infants with Klinefelter syndrome.

Detailed Summary:
Sponsor: University of Colorado, Denver

Current Primary Outcome: Body fat percentage [ Time Frame: 3 months ]

Body fat percentage will be measured using air displacement plethysmography (PEA POD) at the beginning and end of the study period.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Serum Luteinizing Hormone (LH) [ Time Frame: baseline only ]
    Serum will be collected at the first study visit prior to randomization. Ultrasensitive LH will be measured.
  • Serum Follicle Stimulating Hormone (FSH) [ Time Frame: baseline only ]
    Serum will be collected at the first study visit prior to randomization. Ultrasensitive FSH will be measured.
  • Serum Total Testosterone [ Time Frame: baseline only ]
    Serum will be collected at the first study visit prior to randomization. Total testosterone by mass spectroscopy will be measured.
  • Serum Inhibin B (INHB) [ Time Frame: baseline only ]
    Serum will be collected at the first study visit prior to randomization. Inhibin B levels will be measured.
  • Serum Anti-Mullerian Hormone (AMH) [ Time Frame: baseline only ]
    Serum will be collected at the first study visit prior to randomization. AMH levels will be measured.
  • Leptin [ Time Frame: baseline only ]
    Serum will be collected at the first study visit prior to randomization. Leptin levels will be measured.
  • Change in score on the Alberta Infant Motor Scale [ Time Frame: 3 months ]
    Muscle tone and motor development will be assessed by an occupational therapist using the standardized Alberta Infant Motor Scale.
  • Change in score on the Movement Assessment of Infants (MAI). [ Time Frame: 3 months ]
    Muscle tone and motor development will be assessed by an occupational therapist using the standardized Movement Assessment of Infants (MAI).
  • Change in score on the Peabody Developmental Motor Scales 2 [ Time Frame: 3 months ]
    Motor development will be assessed by an occupational therapist using the standardized Peabody Developmental Motor Scales 2.
  • Penile length [ Time Frame: 3 months ]
    Stretched penile length will be measured by a physician before randomization and at the end of the study period.
  • Fat free mass [ Time Frame: 3 months ]
    Fat free mass will be measured using air displacement plethysmography (PEA POD) at the beginning and end of the study period.


Original Secondary Outcome: Same as current

Information By: University of Colorado, Denver

Dates:
Date Received: March 31, 2015
Date Started: May 2015
Date Completion: July 2017
Last Updated: October 27, 2016
Last Verified: October 2016