Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145288
Status:
UNKNOWN
Last Update Posted:
2007-03-26
First Post:
2005-09-02
Brief Title:
Prospective Study of Patients With Hirsutism
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Prospective Study of Patients Med Hirsutism as Primary Work Diagnose
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 66 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
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 66 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
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 66 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 themThe 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 pillsJClinEndocrinolMetab 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 diseaseJClinEndocrinolMetab 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 syndromeDiabetes 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 syndromeJClinEndocrinolMetab 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 populationHumReprod 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 syndromeFertilSteril 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 obesityFertilSteril 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 syndromeHumReprod 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 studyClinEndocrinolOxf 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 diagnosisFertilSteril 2004 82 1570-1579
11 Creatsas G Koliopoulos C and Mastorakos G Combined oral contraceptive treatment of adolescent girls with polycystic ovary syndrome Lipid profileAnnNYAcadSci 2000 900 245-252
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 66 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 themThe 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 pillsJClinEndocrinolMetab 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 diseaseJClinEndocrinolMetab 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 syndromeDiabetes 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 syndromeJClinEndocrinolMetab 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 populationHumReprod 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 syndromeFertilSteril 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 obesityFertilSteril 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 syndromeHumReprod 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 studyClinEndocrinolOxf 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 diagnosisFertilSteril 2004 82 1570-1579
11 Creatsas G Koliopoulos C and Mastorakos G Combined oral contraceptive treatment of adolescent girls with polycystic ovary syndrome Lipid profileAnnNYAcadSci 2000 900 245-252
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None