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

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT00523835

Collaborator

(none)

140

Enrollment

Location

Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Klinefelter Syndrome Diabetes Osteoporosis Metabolic Syndrome Cardiovascular Disease

Study Design

Study Type:

Observational

Observational Model:

Natural History

Time Perspective:

Other

Study Start Date :

Apr 1, 2002

Actual Study Completion Date :

Nov 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
KS Patients with Klinefelter syndrome verified by chromosome analysis
Normal Normal men Age matched to KS patients

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical department M, Endocrinology and Diabetes, and Medical Research Laboratories, Clinical Institute, Aarhus University Hospital	Aarhus		Denmark	8000

Sponsors and Collaborators

University of Aarhus

Investigators

Study Chair: Jens S. Christiansen, Professor, Medical department M, Endocrinology and Diabetes, and Medical Research Laboratories, Clinical Institute, Aarhus University Hospital, Denmark
Principal Investigator: Anders B Bojesen, MD, PhD, Medical department M, Endocrinology and Diabetes, and Medical Research Laboratories, Clinical Institute, Aarhus University Hospital, Denmark
Study Director: Claus H Gravholt, MD, DMsc, PhD, Medical department M, Endocrinology and Diabetes, and Medical Research Laboratories, Clinical Institute, Aarhus University Hospital, Denmark