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Body Composition, Bone Mineral Density, Insulin Sensitivity and Echocardiographic Measurements in Klinefelter Syndrome

NCT ID: NCT00523835

Last Updated: 2007-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-04-30

Study Completion Date

2004-11-30

Brief Summary

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Klinefelter syndrome (KS) is the most common sex-chromosome disorder with a prevalence of one in 660 men and is a frequent cause of hypogonadism and infertility. It is caused by the presence of extra X-chromosomes, the most common karyotype being 47,XXY. The phenotype is variable, but the most constant finding is small hyalinized testes, hypergonadotrophic hypogonadism, infertility, eunuchoid body proportion, increased height and learning disabilities. Klinefelter syndrome has been associated with increased prevalence of diabetes, osteoporosis and cardiovascular diseases but the pathogenesis is unknown. Accordingly the aim of the study was to investigate measures of body composition, insulin sensitivity, bone mineral density, echocardiography, as well as biochemical markers of endocrine, metabolic and bone function in KS and an age-matched control group.

Detailed Description

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Conditions

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Klinefelter Syndrome Diabetes Osteoporosis Metabolic Syndrome Cardiovascular Disease

Study Design

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Observational Model Type

NATURAL_HISTORY

Study Time Perspective

OTHER

Study Groups

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KS

Patients with Klinefelter syndrome verified by chromosome analysis

No interventions assigned to this group

Normal

Normal men Age matched to KS patients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* age above 18 years
* verified KS karyotype (KS patients)

Exclusion Criteria

* untreated hypothyroidism or hyperthyroidism
* present or past malignant diseases
* clinical liver disease
* treatment with drugs knowing to interfere with glucose homeostasis, fat metabolism or bone modulation (e.g. glucocorticoids)
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Principal Investigators

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Jens S. Christiansen, Professor

Role: STUDY_CHAIR

Medical department M, Endocrinology and Diabetes, and Medical Research Laboratories, Clinical Institute, Aarhus University Hospital, Denmark

Anders B Bojesen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical department M, Endocrinology and Diabetes, and Medical Research Laboratories, Clinical Institute, Aarhus University Hospital, Denmark

Claus H Gravholt, MD, DMsc, PhD

Role: STUDY_DIRECTOR

Medical department M, Endocrinology and Diabetes, and Medical Research Laboratories, Clinical Institute, Aarhus University Hospital, Denmark

Locations

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Medical department M, Endocrinology and Diabetes, and Medical Research Laboratories, Clinical Institute, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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Bojesen A, Kristensen K, Birkebaek NH, Fedder J, Mosekilde L, Bennett P, Laurberg P, Frystyk J, Flyvbjerg A, Christiansen JS, Gravholt CH. The metabolic syndrome is frequent in Klinefelter's syndrome and is associated with abdominal obesity and hypogonadism. Diabetes Care. 2006 Jul;29(7):1591-8. doi: 10.2337/dc06-0145.

Reference Type RESULT
PMID: 16801584 (View on PubMed)

Overvad S, Bay K, Bojesen A, Gravholt CH. Low INSL3 in Klinefelter syndrome is related to osteocalcin, testosterone treatment and body composition, as well as measures of the hypothalamic-pituitary-gonadal axis. Andrology. 2014 May;2(3):421-7. doi: 10.1111/j.2047-2927.2014.00204.x. Epub 2014 Mar 21.

Reference Type DERIVED
PMID: 24659579 (View on PubMed)

Other Identifiers

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20010155

Identifier Type: -

Identifier Source: org_study_id