PCOS Clinical Trial
Official title:
Effects of Triple Drug Cocktail Therapy on Metabolic, Endocrine Alterations and Perceived Stress Response in Patients With PCOS: A Double Blind Randomized Clinical Trial
The investigators aim is to conduct a double blind randomized clinical trial, to study the effects of triple drug cocktail (metformin, pioglitazone and acetyl L-Carnitine) therapy on metabolic, endocrine alterations and perceived stress response in patients with Polycystic Ovary Syndrome (PCOS). Women diagnosed with PCOS, using criteria proposed in November 2015, by the American Association of Clinical Endocrinologists (AACE), American College of Endocrinology (ACE), and Androgen Excess and PCOS Society (AES) for PCOS should include two of the following three criteria: chronic an ovulation, hyperandrogenism (clinical/biologic), and polycystic ovaries. The investigators propose that PCOS women may have altered metabolic, endocrine levels and increased perceived stress response and combination therapy may have beneficial influences on these parameters in women diagnosed with PCOS.
Polycystic Ovarian Syndrome (PCOS) is an endocrinopathy which affects 5-10% of reproductive
age women (1). The three main features of the syndrome are polycystic ovaries, high levels of
androgen in blood and chronic an-ovulation/oligo-an ovulation (2). Women with PCOS have a
greater risk of developing hyperinsulinemia and insulin resistance (3). PCOS may lead to
insulin resistance and dyslipidemia (3). Recent long-term follow up studies of the syndrome
have shown that women suffering from the syndrome have hyperlipidemia and enhanced risk of
cardiovascular diseases (3).
Recent evidence has demonstrated that anti-inflammatory drug treatments ameliorate insulin
resistance. Metformin belongs to a family of drugs called the biguanides, currently used as
an antihyperglycemic drug for treatment of type II diabetes mellitus (4). Around 15 years ago
it was reported for the first time that use of metformin in PCOS effectively reduced insulin
resistance (4). Increasing evidence has shown the importance of metformin not only in
hyperinsulinemic patients but also in PCOS resolving several other issues like menstrual
cycles, fertility, hormonal imbalance and metabolic syndromes (4). Pioglitazone is a drug
from class thiazolidinedione (TZD) with hypoglycemic (anti-hyperglycemic, anti-diabetic)
action in the management of type 2 diabetes (5). Recent studies have shown that pioglitazone
may be considered a new treatment option for patients with PCOS, since it is able to restore
normal menstrual cycle and have improved ovulation (6). Recent randomized placebo controlled
clinical trials have also shown that it is associated with good serum lipid profile levels
(7).
Acetyl L-Carnitine is an isomer synthesized by two amino acids lysine and methionin mainly
distributed among skeletal and cardiac muscles in mammals (8, 9). Acetyl L-Carnitine is
involved in fatty acid oxidation by transporting long chain fatty acids into mitochondria for
oxidation to produce metabolic energy and have effects on oxidative metabolism of glucose in
tissues (9). Acetyl L-Carnitine is known to regulate energy production (10). Studies have
shown that patients treated with acetyl L-Carnitine have improved ovulation and pregnancy
rates and is well tolerated by the patients (8). PCOS patients have shown reduced adiponectin
levels associated with insulin resistance states and type 2 diabetes mellitus and treatment
with L-Carnitine has shown reduced blood glucose levels, increased insulin sensitivity and
also improved adiponectin levels, which can be attributed to L-carnitine-induced increase in
beta-oxidation of fatty acids and basal metabolic rates (11).
PCOS is a systemic condition, an endocrinopathy whose etiology is still not understood.
Correct treatment regimens of PCOS will not only improve menstrual cycles of the patients but
will also improve the metabolic or endocrine parameters (2). PCOS sufferers are also known to
have increased perceived stress response which will be considered in the study. Little
evidences are available on combination therapy for treatment of PCOS patients. The aim of
this study is to come up with a better treatment option to ameliorate the signs and symptoms
associated with the disease.
Study objectives:
To find the effects of triple drug cocktail therapy (metformin, pioglitazone and acetyl
L-Carnitine) on metabolic, endocrine alterations and perceived stress response in patients
with PCOS.
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