Type 2 Diabetes Clinical Trial
Official title:
Prospective Study of Patients Med Hirsutism as Primary Work Diagnose
Verified date | March 2007 |
Source | Odense University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: National Board of Health |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 340 |
Est. completion date | March 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - The patients which had been included in the previous study between 1997 – 2000, oral glucose tolerance test included. Exclusion Criteria: - Pregnancy |
Observational Model: Case Control, Time Perspective: Longitudinal
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Endocrinology, Odense University Hospital | Odense | Funen |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital |
Denmark,
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