Prospective Study of Patients With Hirsutism
|ClinicalTrials.gov Identifier: NCT00145288|
Recruitment Status : Unknown
Verified March 2007 by Odense University Hospital.
Recruitment status was: Active, not recruiting
First Posted : September 5, 2005
Last Update Posted : March 26, 2007
Hirsutism is the presence of terminal hairs in a male-like pattern in females, due to elevated male hormone levels. Females with hirsutism are often overweight and have metabolism disturbances as insulin resistance and impaired glucose tolerance.
The previous studies showed that patients with hirsutism (especially them with polycystic ovarian syndrome (PCOS)) have an increased risk to develop type 2 diabetes mellitus on the background of insulin resistance / hyperinsulinemia: 30-35 % of females with PCOS had impaired glucose tolerance and 5-10 % of them diabetes. Hyperinsulinemia increases the risk to develop dyslipidemia and cardiovascular diseases.
A previous study in our department who included 340 females with hirsutism (210 with idiopathic hirsutism and 134 with PCOS) showed that 6.6% of them had diabetes and 55% insulin resistance.
There were only few long-term follow up studies of patients with hirsutism concerning their risk to develop diabetes. As far as we now, such studies on patients with idiopathic hirsutism are not available until now.
Hirsutism is been treated with low dose oral contraceptives, which are suppressing androgen production. This treatment can also influence the risk to develop diabetes and atheromatosis. The previous studies showed that the low dose oral contraceptives had modest influence on the lipid profiles and carbohydrate metabolism in patients with hirsutism, but increased the risk to develop coronary disease.
- To study and quantify, in patients with hirsutime, the risk to develop type 2 diabetes on the background of insulin resistance / decreased glucose tolerance and atheromatosis on the background of insulin resistance / hypercholesterolemia.
- To clarify the effect of P-pills on patients hair growth and metabolism.
|Condition or disease||Phase|
|Hirsutism Type 2 Diabetes Polycystic Ovary Syndrome||Phase 2 Phase 3|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||340 participants|
|Observational Model:||Case Control|
|Observational Model:||Natural History|
|Official Title:||Prospective Study of Patients Med Hirsutism as Primary Work Diagnose|
|Study Start Date :||October 2003|
|Estimated Study Completion Date :||March 2005|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00145288
|Department of Endocrinology, Odense University Hospital|
|Odense, Funen, Denmark, 5000|
|Principal Investigator:||Magdalena Andries, MD||Odense University Hospital|