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Status unknownNCT00145288Updated Mar 26, 2007

Prospective Study of Patients With Hirsutism

An observational study in Hirsutism, Type 2 Diabetes and Polycystic Ovary Syndrome, sponsored by Odense University Hospital. Status unknown at 1 site in Denmark. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2007-03-26.

Sponsored by Odense University Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2007), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
340
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.
Read the 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
02

Conditions studied

  • Hirsutism
  • Type 2 Diabetes
  • Polycystic Ovary Syndrome

Keywords

  • hirsutism
  • type 2 diabetes
  • polycystic ovary syndrome
  • metabolism
03

In context

Hirsutism

41 studies on the registry are indexed under Hirsutism; 8 are open to participants now.

This study's enrollment of 340 is above the median of 206 across 14 observational studies indexed under Hirsutism.

Browse Hirsutism studies →

Lead sponsor

Odense University Hospital is the lead sponsor of 479 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
340 participants
06

Study locations

1 site
  • Department of Endocrinology, Odense University Hospital
    Odense, Funen 5000, Denmark
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2003 and a completion of Mar 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2005
First posted
Sep 5, 2005
Start
Oct 2003
Completion
Mar 2005
Last update
Mar 26, 2007
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on Mar 26, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00145288
First posted
Sep 5, 2005
Start date
Oct 2003
Completion
Mar 2005
Last update
Mar 26, 2007

Study contacts

Magdalena Andries, MD
principal investigator · Odense University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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