Clinical trial NCT01279512: Metformin Versus Acarbose Treatment in Infertile Overweight Women With Polycystic Ovary Syndrome (PCOS)
Official title: Metformin vs. Acarbose Treatment in Infertile Overweight Women With PCOS: A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PCO
Keywords: Metformin Acarbose pco infertility overweight
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2011-01-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a prospective randomized clinical trial to compare the endocrine and metabolic effects of two anti diabetic drugs (metformin vs. acarbose) in infertile overweight women with PCOS

Detailed description: This study is a prospective randomized clinical trial to compare the endocrine and metabolic effects of two anti diabetic drugs (metformin vs. acarbose) in infertile overweight women with PCOS.

Polycystic ovary syndrome (PCOS) is characterized by menstrual irregularity, hyperandrogenism, chronic anovulation and enlarged ovaries with more than twelve peripherally located follicles less than 10 mm in diameter. Hyperinsulinemia is one of the diagnostic features of PCOS and patients with PCOS are found to have resistance to either endogenous or exogenous insulin. Different insulin sensitizing drugs used for improvement of hyperinsulinemia in PCOS subjects. Metformin (N dimethyl-biguanide) is an anti diabetic drug that increases glucose utilization in insulin sensitive tissues. Acarbose is an alfa-Glycosidase inhibitor acts by slowing the absorption of carbohydrates from the intestine, prevents Glucosidase activity in the brush-border of the intestinal mucosa, decreasing disaccharide digestion, reducing enteric monosaccharide absorption, so minimizing the postprandial rise of blood glucose concentration. The aim of present study is to compare the endocrine and metabolic effects of these two antidiabetic drugs (metformin vs. acarbose) in infertile overweight women with PCOS.

The study population comprises all infertile patients with diagnosis of polycystic ovarian syndrome who were overweight (BMI\>25Kg/m2). The PCO subjects will be recognized based on the Rotterdam criteria inclusive 1) irregular menstruation, 2) clinical and /or biochemical signs of hyperandrogenism, 3) polycystic ovaries (presence of 12 or more follicles in each ovary measuring 2-9 mm in diameter, and /or increased ovarian volume greater than 10 ml). Diagnosis of PCOS was confirmed by the presence two of three criteria beside the infertility.

In this study all eligible patients will be randomly allocated into two study groups by a computerized randomization method:

Acarbose group will be treated by acarbose (its dose will be 100 mg/day in the first week, 200 mg/ day in the second week and 300 mg/ day for the next 10 weeks). Metformin group will be received metformin. The metformin dose will be 500 mg/ day in the first week, 1000 mg/ day in the second week and 1500 mg/ day for the next 10 weeks.

Data collection will be performed by using questionnaire to be filled as per the available records and laboratory results. This study will be accomplished in Royan Institute on 50 PCO patients (25 patients in each group) and a continuous sampling method will be applied. Data analysis will be done through descriptive and perceptive statistical methods by using SPSS software version 15 for windows.

Eligibility criteria: Inclusion Criteria:

* Poly Cystic Ovarian Syndrome patients
* Age \< 40 years
* BMI \> 25 kg/m2

Exclusion Criteria:

* Smoking
* Overt diabetes mellitus, hyperprolactinemia, diseases that would disturb clinical and hormonal responses (adrenal disease or tumors, ovarian tumors, thyroid disease)
* The use of hormonal medications or drugs that might interfere with carbohydrate metabolism over the last 6 months.

Primary outcomes:
measure: Weight reduction (BMI improvement)
timeFrame: After 3 months of Metformin or Acarbose
Secondary outcomes:
measure: Fasting blood sugar (FBS)
timeFrame: two hours post prandial blood sugar
measure: FSH
timeFrame: 6 months
measure: LH
timeFrame: 6 months
measure: Estradiol
timeFrame: 6 months
measure: Prolactin
timeFrame: 6 months
measure: Total testosterone
timeFrame: 6 months
measure: Total cholesterol
timeFrame: 6 months
measure: triglyceride
timeFrame: 6 months
measure: High density Lipoprotein
timeFrame: 6 months
measure: Low density lipoprotein
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Scientific board
name: Ashraf Moini, MD
role: STUDY_CHAIR
affiliation: Invetigator
name: Elham Amirchaghmaghi, MD
role: STUDY_DIRECTOR
affiliation: Investigator
name: Zhila Ahmadi, BS.c
role: PRINCIPAL_INVESTIGATOR
affiliation: Investigator
name: Bita Eslami, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Investigator
name: Ali asghar Akhlaghi, BS.c
role: PRINCIPAL_INVESTIGATOR
affiliation: Investigator
name: Reza salmanyazdi, MLD
role: PRINCIPAL_INVESTIGATOR
References: