NCT00145288

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2003

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
Last Updated

March 26, 2007

Status Verified

March 1, 2007

First QC Date

September 2, 2005

Last Update Submit

March 23, 2007

Conditions

Keywords

hirsutismtype 2 diabetespolycystic ovary syndromemetabolism

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Odense University Hospital

Odense, Funen, 5000, Denmark

Location

MeSH Terms

Conditions

HirsutismDiabetes Mellitus, Type 2Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Hair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesVirilismSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal Disorders

Study Officials

  • Magdalena Andries, MD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

October 1, 2003

Study Completion

March 1, 2005

Last Updated

March 26, 2007

Record last verified: 2007-03

Locations