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

Klinefelter Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02408445
• Other study ID #: 14-1720
• Secondary ID: UL1TR001082
• Status: Completed
• Phase: Phase 4
• Start date: May 8, 2015
• Est. completion date: January 1, 2020

Study information

• Verified date: April 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 1, 2020
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 42 Days to 108 Days

Eligibility

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.

Related Conditions & MeSH terms

• Klinefelter Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Fat Percent Z-score	Body fat percentage will be measured using air displacement plethysmography (PEA POD) at the beginning and end of the study period. Age and sex-normed z-scores will be calculated. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Change in the z-score over time, if following a normal growth curve, is 0. Positive change in z-scores indicates a gain in body fat above growth typically expected. Negative change in z-scores indicates a gain in body fat that is less than typically expected.	Baseline and 3 months
Secondary	Serum Luteinizing Hormone (LH)	Serum will be collected at the first study visit prior to randomization. Ultrasensitive LH will be measured.	baseline only
Secondary	Serum Follicle Stimulating Hormone (FSH)	Serum will be collected at the first study visit prior to randomization. Ultrasensitive FSH will be measured.	baseline only
Secondary	Serum Total Testosterone	Serum will be collected at the first study visit prior to randomization. Total testosterone by mass spectroscopy will be measured.	baseline only
Secondary	Serum Inhibin B (INHB)	Serum will be collected at the first study visit prior to randomization. Inhibin B levels will be measured.	baseline only
Secondary	Serum Anti-Mullerian Hormone (AMH)	Serum will be collected at the first study visit prior to randomization. AMH levels will be measured.	baseline only
Secondary	Leptin	Serum will be collected at the first study visit prior to randomization. Leptin levels will be measured.	baseline only
Secondary	Change in Raw Score on the Alberta Infant Motor Scale	Muscle tone and motor development will be assessed by an occupational therapist using the standardized Alberta Infant Motor Scale (AIMS). The AIMS scale measures infant motor maturation from birth until the age of independent walking. An occupational therapists assesses 58 motor behavior items in 4 position categories: prone (21 items), supine (9 items), sitting (12 items) & standing(16 standing). Each item receives one point (range of raw scores 0-58), with higher scores indicating more skills acquired. For change in scores, the raw score at 3 months was subtracted from the baseline raw score.	3 months
Secondary	Change in Score on the Movement Assessment of Infants (MAI)	Muscle tone and motor development will be assessed by an occupational therapist using the standardized Movement Assessment of Infants (MAI). The MAI evaluates four domains: muscle tone, primitive reflex, automatic reactions and volitional movement. All items are scored 1-5 and summed to generate a "Total Risk Score". Lower scores indicate better function, and Total Risk Scores of 8 or more indicate high risk.	3 months
Secondary	Change in Total Motor Standard Score on the Peabody Developmental Motor Scales 2	Motor development will be assessed by an occupational therapist using the standardized Peabody Developmental Motor Scales 2. Standard scores are normalized to age with a mean of 100 and standard deviation of 15. Change in standard score was calculated as the differences between the subject's standard score at 3 months minus the standard score at baseline. A positive change in standard scores would indicate greater growth on the measure relative to peers, while a negative number would indicate slower growth on the measure relative to peers.	3 months
Secondary	Change in Penile Length	Stretched penile length will be measured by a physician before randomization and at the end of the study period.	Baseline and 3 months
Secondary	Change in Fat Free Mass	Fat free mass (lean mass) will be measured using air displacement plethysmography (PEA POD) at the beginning and end of the study period.	Baseline and 3 months