Bone Status and Insulin Resistance in Hirsutism

NCT ID: NCT00143052

Last Updated: 2008-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-01-31

Study Completion Date

2007-01-31

Brief Summary

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The purpose of this study is to investigate how the bones of hirsute women are different from bones of healthy women. The change in hormone content in the blood will also be investigated. The study can be used to evaluate whether it will be relevant to bone scan all newly referred hirsute women.

Hirsute women are often over-weight and often have an increased amount of the male sex hormone in their blood. Their blood tests often show changes reminding of the ones seen in diabetic patients.

All hirsute women referred to the department will undergo an investigation revealing the reason for the increased hair growth. The investigation includes clinical investigation (height, weight and degree of hair growth), blood tests (for hormone status and bone status analysis) and bone scanning of the abdomen (body composition).

The trial includes a group of 50 strongly hairy women and a control group of 50 healthy women with normal hair growth. They are matched by body weight, since weight has great importance for the bone mineral content and thereby for osteoporosis in the long run.

Detailed Description

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Conditions

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Hirsutism

Keywords

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Hirsutism Bone status Androgens insulin

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Hirsute subjects:

* Belonging to group 1 or 2.
* Age: 20-46
* Hirsute score: \>7
* Written informed consent

Control group:

* Age: 20-46
* Hirsute score: 0 (without razing)
* Regular menses
* Written informed consent

Exclusion Criteria

* Previous cosmetic treatment for hirsutism.
* Use of contraceptive pill (within the past 6 months)
* Systemic steroid treatment \> 6 weeks (ever)
* Age above 46 years/post menopause (increased FSH)
* Recognized diabetes mellitus or other endocrine disease
* Eating disorder
* Serious, treatment demanding disease
Minimum Eligible Age

20 Years

Maximum Eligible Age

46 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Odense University Hospital

Principal Investigators

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Dorte Glintborg, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

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Diabetes Research Center

Odense, Funen, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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003

Identifier Type: -

Identifier Source: org_study_id