Prospective Study of Patients With Hirsutism

March 23, 2007 updated by: Odense University Hospital

Prospective Study of Patients Med Hirsutism as Primary Work Diagnose

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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 (1, 2, 3, 4). Hyperinsulinemia increases the risk to develop dyslipidemia and cardiovascular diseases (5, 6, 7, 8, 9).

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 (10).

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 (11).

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.

Design The patients who had previously included in the study between1997 - 2000 (231) will be contacted in order to be followed. We will estimate the grad of excess hair growth, the hormonal and metabolism profiles.

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

Exclusion criteria Pregnancy.

Investigations

Anamnesis: previous treatment, pregnancy / in-utero fertilisation history, family predisposition to diabetes and cardiovascular diseases.

Clinical examination: Ferriman-Gallwey score, body mass index (BMI), waist / hip ratio (WHR), blood pressure.

Blood analyses:

  • Metabolism profile (oral glucose tolerance test, lipid profile);
  • Hormonal profile (androgen and oestrogen levels, prolactin, FH, FSH).

The ethic aspects

We want to evaluate the effect of the treatment and how the risk factors are influenced by the treatment.

All the patients will receive both oral and written information about the study. It will be emphasised at participation is voluntary and the informed consent can be retracted at any time and this will not influence the treatment of them.The trial is validated by the local ethics committee.

The project will be carried on The Endocrinology Department, Odense University Hospital, Denmark, which will supply technical assistance. Blood analyses will be founded by private founds.

References

  1. Diamanti-Kandarakis, E., Baillargeon, J. P., Iuorno, M. J., Jakubowicz, D. J., and Nestler, J. E. A modern medical quandary: polycystic ovary syndrome, insulin resistance, and oral contraceptive pills.J.Clin.Endocrinol.Metab 2003 88 1927-1932
  2. Arslanian, S. A., Lewy, V. D., and Danadian, K. Glucose intolerance in obese adolescents with polycystic ovary syndrome: roles of insulin resistance and beta-cell dysfunction and risk of cardiovascular disease.J.Clin.Endocrinol.Metab 2001 86 66-71
  3. Ehrmann, D. A., Barnes, R. B., Rosenfield, R. L., Cavaghan, M. K., and Imperial, J. Prevalence of impaired glucose tolerance and diabetes in women with polycystic ovary syndrome.Diabetes Care 1999 22 141-146
  4. Palmert, M. R., Gordon, C. M., Kartashov, A. I., Legro, R. S., Emans, S. J., and Dunaif, A. Screening for abnormal glucose tolerance in adolescents with polycystic ovary syndrome.J.Clin.Endocrinol.Metab 2002 87 1017-1023
  5. Elting, M. W., Korsen, T. J., Bezemer, P. D., and Schoemaker, J. Prevalence of diabetes mellitus, hypertension and cardiac complaints in a follow-up study of a Dutch PCOS population.Hum.Reprod. 2001 16 556-560
  6. Loucks, T. L., Talbott, E. O., McHugh, K. P., Keelan, M., Berga, S. L., and Guzick, D. S. Do polycystic-appearing ovaries affect the risk of cardiovascular disease among women with polycystic ovary syndrome?Fertil.Steril. 2000 74 547-552
  7. Mather, K. J., Kwan, F., and Corenblum, B. Hyperinsulinemia in polycystic ovary syndrome correlates with increased cardiovascular risk independent of obesity.Fertil.Steril. 2000 73 150-156
  8. Vrbikova, J., Cifkova, R., Jirkovska, A., Lanska, V., Platilova, H., Zamrazil, V., and Starka, L. Cardiovascular risk factors in young Czech females with polycystic ovary syndrome.Hum.Reprod. 2003 18 980-984
  9. Wild, S., Pierpoint, T., McKeigue, P., and Jacobs, H. Cardiovascular disease in women with polycystic ovary syndrome at long-term follow-up: a retrospective cohort study.Clin.Endocrinol.(Oxf) 2000 52 595-600
  10. Glintborg, D., Henriksen, J. E., Andersen, M., Hagen, C., Hangaard, J., Rasmussen, P. E., Schousboe, K., and Hermann, A. P. Prevalence of endocrine diseases and abnormal glucose tolerance tests in 340 Caucasian premenopausal women with hirsutism as the referral diagnosis.Fertil.Steril. 2004 82 1570-1579
  11. Creatsas, G., Koliopoulos, C., and Mastorakos, G. Combined oral contraceptive treatment of adolescent girls with polycystic ovary syndrome. Lipid profile.Ann.N.Y.Acad.Sci. 2000 900 245-252

Study Type

Observational

Enrollment

340

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

  • Denmark
    • Funen
      • Odense, Funen, Denmark, 5000
        • Department of Endocrinology, Odense University Hospital

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

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Principal Investigator: Magdalena Andries, MD, Odense University Hospital

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

October 1, 2003

Study Completion

March 1, 2005

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (ESTIMATE)

September 5, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

March 26, 2007

Last Update Submitted That Met QC Criteria

March 23, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 010

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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