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Prospective Study of Patients With Hirsutism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Odense University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00145288
First received: September 2, 2005
Last updated: March 23, 2007
Last verified: March 2007
  Purpose

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.

Aim

  • 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 Phase
Hirsutism
Type 2 Diabetes
Polycystic Ovary Syndrome
Phase 2
Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Longitudinal
Official Title: Prospective Study of Patients Med Hirsutism as Primary Work Diagnose

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Estimated Enrollment: 340
Study Start Date: October 2003
Estimated Study Completion Date: March 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patients which had been included in the previous study between 1997 – 2000, oral glucose tolerance test included.

Exclusion Criteria:

  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145288

Locations
Denmark
Department of Endocrinology, Odense University Hospital
Odense, Funen, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Magdalena Andries, MD Odense University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00145288     History of Changes
Other Study ID Numbers: 010
Study First Received: September 2, 2005
Last Updated: March 23, 2007
Health Authority: Denmark: National Board of Health

Keywords provided by Odense University Hospital:
hirsutism
type 2 diabetes
polycystic ovary syndrome
metabolism

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Hirsutism
Hypertrichosis
Polycystic Ovary Syndrome
Syndrome
Adnexal Diseases
Cysts
Diabetes Mellitus
Disease
Endocrine System Diseases
Genital Diseases, Female
Glucose Metabolism Disorders
Gonadal Disorders
Hair Diseases
Metabolic Diseases
Neoplasms
Ovarian Cysts
Ovarian Diseases
Pathologic Processes
Signs and Symptoms
Skin Diseases
Virilism

ClinicalTrials.gov processed this record on November 24, 2014