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

Tracking Information

First Received Date ^ICMJE

August 31, 2007

Last Updated Date

August 31, 2007

Start Date ^ICMJE

April 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Natural History, Cross-Sectional, Convenience Sample, Prospective Study

Condition ^ICMJE

Klinefelter Syndrome
Diabetes
Osteoporosis
Metabolic Syndrome
Cardiovascular Disease

Intervention ^ICMJE

Study Arms / Comparison Groups

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

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

140

Completion Date

November 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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)

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00523835

Responsible Party

Study ID Numbers ^ICMJE

20010155

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

University of Aarhus

Verification Date

August 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP