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

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ClinicalTrials.gov Identifier: NCT02408445
Recruitment Status : Active, not recruiting
First Posted : April 3, 2015
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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. The Investigators 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. The Investigators will learn if body composition and motor skills are improved with testosterone treatment in infants with Klinefelter syndrome.

Condition or disease Intervention/treatment Phase
Klinefelter Syndrome Drug: testosterone cypionate 200mg/ml Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment
Actual Study Start Date : May 8, 2015
Actual Primary Completion Date : January 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Testosterone treatment
Testosterone cypionate (200 mg/ml) intramuscular injection
Drug: testosterone cypionate 200mg/ml
Subjects in this group will be randomized to receive testosterone cypionate 200 mg/ml to be given intramuscularly every 4 weeks for a total of 3 doses.

No Intervention: No treatment
Subjects will not receive any testosterone during the study period.



Primary Outcome Measures :
  1. Change in Body Fat Percentage [ Time Frame: Baseline and 3 months ]
    Body fat percentage will be measured using air displacement plethysmography (PEA POD) at the beginning and end of the study period.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Leptin [ Time Frame: baseline only ]
    Serum will be collected at the first study visit prior to randomization. Leptin levels will be measured.

  7. 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.

  8. 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).

  9. 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.

  10. Change in Penile length [ Time Frame: Baseline and 3 months ]
    Stretched penile length will be measured by a physician before randomization and at the end of the study period.

  11. Change in Fat free mass [ Time Frame: Baseline and 3 months ]
    Fat free mass will be measured using air displacement plethysmography (PEA POD) at the beginning and end of the study period.



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Ages Eligible for Study:   42 Days to 108 Days   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male infants with 47,XXY karyotype

Exclusion Criteria:

  • Gestational age at birth <36 weeks
  • Birth weight <5%ile or >95% for gestational age
  • History of thrombosis in a first degree relative
  • Exposure to androgen therapy outside of the study protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02408445


Locations
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Shanlee M Davis, MD University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02408445     History of Changes
Other Study ID Numbers: 14-1720
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

Keywords provided by University of Colorado, Denver:
body composition
Klinefelter syndrome
XXY
sex chromosome variation
sex chromsome aneuploidy

Additional relevant MeSH terms:
Syndrome
Klinefelter Syndrome
Disease
Pathologic Processes
Sex Chromosome Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Hypogonadism
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents