Ignite Creation Date:
2024-05-05 @ 9:55 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00988078
Status:
UNKNOWN
Last Update Posted:
2012-06-26
First Post:
2009-09-30
Brief Title:
Effects of Metformin and Oral Hormonal Contraceptive in Adolescents With Polycystic Ovary Syndrome
Sponsor:
Federal University of São Paulo
Organization:
Federal University of São Paulo
Study Overview
Official Title:
Effect of Metformin Therapy on Insulin Resistance and Melatonin in Adolescents With Polycystic Ovary Syndrome
Status:
UNKNOWN
Status Verified Date:
2009-10
Last Known Status:
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:
The polycystic ovary syndrome is the most common endocrinopathy in reproductive age women The pathophysiology of this syndrome remains unclear but there are evidences that a decreased in insulin sensitivity may be related in this syndrome There are studies that showed the action of factors on the sensitivity of the insulin receptor such as melatonin It is a hormone produced by the pineal gland whose role is still uncertain in human reproduction although many studies have found that it may relate sex hormone effect Many patients with polycystic ovary syndrome PCOS may have hyperinsulinemia and that pinealectomized rats determined hypoglycemia and hyperinsulinemia with reduced release of insulin in response to glucose Therefore it is supposed that blood levels of melatonin might correlate with the blood insulin concentration in patients with the syndrome Moreover the insulin sensitizing agents have been used in the treatment of patients with insulin resistance and PCOS based on its main pathophysiological substrate which is the hyperinsulinemia In fact the metformin is the most used in the literature However there are few studies on the use of metformin in adolescents The evidences of this drugs in this group of patients have showed good therapeutic response with few side effects The objective of the study is to evaluate the effects of metformin on insulin resistance and levels of melatonin in adolescents with PCOS It will be performed a prospective randomized double-blind and placebo-controlled study with 90 adolescents with PCOS It will be evaluated clinical and laboratory parameters TSH free T4 prolactin FSH LH estradiol total testosterone androstenedione DHEA-s 17-OH progesterone SHBG free androgen index index of HOMA-IR and QUICKI from fasting glucose and insulin total cholesterol and fractions triglycerides creatinine AST and ALT and creatinkinase fibrinogen and PAI-1 and melatonin for 6 months of treatment
Detailed Description:
Design 90 patients will be selected to a prospective randomized and double-blinded study They will be assigned to two groups A 45 patients treated with OC oral contraceptive and metformin 1500mg day B 45 patients treated with OC and placebo The length of treatment was six months
Inclusion criteria patients until 19 years-old at least 2 years after menarche with Polycystic Ovary Syndrome based on Rotterdan criterion Exclusion criteria patients with Diabetes Mellitus hypertension hyperprolactinemia adrenal enzymatic deficiency Cushing syndrome thyroidopathy renal or hepatic disfunction use of OC or insulin-sensitising drugs in the last 90 days before pregnancy androgen tumors hormonal-sensitive tumors in the past contra-indication to the medications used in the study
Clinical parameters included are weight and height for BMI waist to hip ratio habits like smoking or drinking drug addiction blood pressure measurement hirsutism and acne
Laboratorial parameters included are TSH free T4 prolactin FSH LH estradiol total testosterone androstenedione s-DHEA 17-OH progesterone SHBG free androgen index fasting glucose and insulin total cholesterol and fractions triglycerides creatinin TGO TGP CK PAI-1 fibrinogen melatonin
Patients will be evaluated using these parameters in the beginning 1 3 and 6 months after use of the drugs
Inclusion criteria patients until 19 years-old at least 2 years after menarche with Polycystic Ovary Syndrome based on Rotterdan criterion Exclusion criteria patients with Diabetes Mellitus hypertension hyperprolactinemia adrenal enzymatic deficiency Cushing syndrome thyroidopathy renal or hepatic disfunction use of OC or insulin-sensitising drugs in the last 90 days before pregnancy androgen tumors hormonal-sensitive tumors in the past contra-indication to the medications used in the study
Clinical parameters included are weight and height for BMI waist to hip ratio habits like smoking or drinking drug addiction blood pressure measurement hirsutism and acne
Laboratorial parameters included are TSH free T4 prolactin FSH LH estradiol total testosterone androstenedione s-DHEA 17-OH progesterone SHBG free androgen index fasting glucose and insulin total cholesterol and fractions triglycerides creatinin TGO TGP CK PAI-1 fibrinogen melatonin
Patients will be evaluated using these parameters in the beginning 1 3 and 6 months after use of the drugs
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