Metformin Versus Acarbose Treatment in Infertile Overweight Women With Polycystic Ovary Syndrome (PCOS)

NCT ID: NCT01279512

Last Updated: 2012-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-12-31

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.

Conditions

PCO

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Metformin reciepiants

Infertile overweight women with PCO who received Metformin

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

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.

Acarbose reciepiants

Infertile overweight women with PCO who received Acarbose

Group Type: EXPERIMENTAL

Acarbose

Intervention Type: DRUG

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).

Interventions

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.

Intervention Type: DRUG

Acarbose

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).

Intervention Type: DRUG

Other Intervention Names

Metformin description; Acarbose description

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Royan Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashraf Moini, MD

Role: STUDY_CHAIR

Scientific board

Elham Amirchaghmaghi, MD

Role: STUDY_DIRECTOR

Invetigator

Zhila Ahmadi, BS.c

Role: PRINCIPAL_INVESTIGATOR

Investigator

Bita Eslami, MPH

Role: PRINCIPAL_INVESTIGATOR

Investigator

Ali asghar Akhlaghi, BS.c

Role: PRINCIPAL_INVESTIGATOR

Investigator

Reza salmanyazdi, MLD

Role: PRINCIPAL_INVESTIGATOR

Investigator

Locations

Royan Institute

Tehran, , Iran

Countries

Iran

Related Links

http://www.royaninstitute.org

RoyanInstitute

Other Identifiers

Royan-Emb-011

Identifier Type: -

Identifier Source: org_study_id