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HirsutismNCT00145288

Prospective Study of Patients With Hirsutism

An observational study of Hirsutism and Type 2 Diabetes, run by Odense University Hospital at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
How many people
340 participants
Where
1 siteDenmark
Study dates
Oct 2003to Mar 2005
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Department of Endocrinology, Odense University Hospital

    Odense, Funen, 5000

Other trials in Denmark

About this study

Official title: 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.

Read more

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
Keywords
hirsutism, type 2 diabetes, polycystic ovary syndrome, metabolism
Medical subject headings
Hirsutism, Diabetes Mellitus, Type 2, Polycystic Ovary Syndrome

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2005 (estimated)
  2. Study startOct 2003
  3. Study completionMar 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
340 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00145288
Sponsor's protocol ID
010
Status last verified
Mar 2007
First submitted
2 Sep 2005
Last updated
26 Mar 2007
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hirsutism and Type 2 Diabetes, run by Odense University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2007.

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