Body Composition, Bone Mineral Density, Insulin Sensitivity and Echocardiographic Measurements in Klinefelter Syndrome - Full Text View

Sponsor:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00523835

Purpose

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
Klinefelter Syndrome Diabetes Osteoporosis Metabolic Syndrome Cardiovascular Disease

Study Type:	Observational
Study Design:	Natural History, Cross-Sectional, Convenience Sample, Prospective Study

Resource links provided by NLM:

Genetics Home Reference related topics: Klinefelter syndrome

MedlinePlus related topics: Diabetes Klinefelter's Syndrome Minerals Osteoporosis

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Estimated Enrollment:	140
Study Start Date:	April 2002
Study Completion Date:	November 2004

Groups/Cohorts
KS: Case Patients with Klinefelter syndrome verified by chromosome analysis
Normal: Control Normal men Age matched to KS patients

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523835

Locations

Denmark
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

More Information

Publications:

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.

Study ID Numbers:	20010155
Study First Received:	August 31, 2007
Last Updated:	August 31, 2007
ClinicalTrials.gov Identifier:	NCT00523835 History of Changes
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:

Disease
Gonadal Disorders
Klinefelter Syndrome
Chromosome Disorders
Osteoporosis
Endocrine System Diseases
Bone Diseases, Metabolic
Bone Diseases
Sex Differentiation Disorders

Pathologic Processes
Urogenital Abnormalities
Hypogonadism
Musculoskeletal Diseases
Genetic Diseases, Inborn
Syndrome
Sex Chromosome Disorders
Cardiovascular Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on November 25, 2009