- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00523835
Body Composition, Bone Mineral Density, Insulin Sensitivity and Echocardiographic Measurements in Klinefelter Syndrome
August 31, 2007 updated by: University of Aarhus
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment
140
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aarhus, Denmark, 8000
- Medical department M, Endocrinology and Diabetes, and Medical Research Laboratories, Clinical Institute, Aarhus University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Natural History
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
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KS
Patients with Klinefelter syndrome verified by chromosome analysis
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Normal
Normal men Age matched to KS patients
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.2337/dc06-0145.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2002
Study Completion (Actual)
November 1, 2004
Study Registration Dates
First Submitted
August 31, 2007
First Submitted That Met QC Criteria
August 31, 2007
First Posted (Estimate)
September 3, 2007
Study Record Updates
Last Update Posted (Estimate)
September 3, 2007
Last Update Submitted That Met QC Criteria
August 31, 2007
Last Verified
August 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Disease
- Gonadal Disorders
- Disorders of Sex Development
- Urogenital Abnormalities
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Musculoskeletal Diseases
- Insulin Resistance
- Hyperinsulinism
- Bone Diseases
- Bone Diseases, Metabolic
- Chromosome Disorders
- Sex Chromosome Disorders
- Sex Chromosome Disorders of Sex Development
- Hypogonadism
- Cardiovascular Diseases
- Syndrome
- Metabolic Syndrome
- Osteoporosis
- Klinefelter Syndrome
Other Study ID Numbers
- 20010155
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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