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

Metformin vs. Acarbose Treatment in Infertile Overweight Women With PCOS: A Prospective Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: PCO
• Intervention / Treatment: Drug: Metformin; Drug: Acarbose

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Royan Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metformin reciepiants; Infertile overweight women with PCO who received Metformin	Drug: 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.; Other Names: Metformin description
Experimental: Acarbose reciepiants; Infertile overweight women with PCO who received Acarbose	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).; Other Names: Acarbose description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight reduction (BMI improvement)	compare the effect of Metformin and Acarbose to weight reduction	After 3 months of Metformin or Acarbose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting blood sugar (FBS)	Compare the effect of Metformin and acarbose to fasting blood sugar reduction	two hours post prandial blood sugar
FSH	compare the effect of Metformin and Acarbose to decrease the level of FSH	6 months
LH	compare the effect of Metformin and Acarbose to decrease the level of LH	6 months
Estradiol	compare the effect of Metformin and Acarbose to decrease the Esteradiol level	6 months
Prolactin	compare the effect of Metformin and Acarbose to decrease the Prolactin level	6 months
Total testosterone	compare the the effect of Metformin and Acarbose to decrease Total testosterone level	6 months
Total cholesterol	comparethe the effect of Metformin and Acarbose to decrease total cholesterol level	6 months
triglyceride	comparethe the effect of Metformin and Acarbose to decrease the triglyceride level	6 months
High density Lipoprotein	compare the the effect of Metformin and Acarbose to decrease high density lipoprotein	6 months
Low density lipoprotein	compare the the effect of Metformin and Acarbose to decrease Low Density Lipoprotein	6 months

Collaborators and Investigators

• Sponsor: Royan Institute
• Investigators: Study Chair: Ashraf Moini, MD, Scientific Board; Study Director: Elham Amirchaghmaghi, MD, Invetigator; Principal Investigator: Zhila Ahmadi, BS.c, Investigator; Principal Investigator: Bita Eslami, MPH, Investigator; Principal Investigator: Ali asghar Akhlaghi, BS.c, Investigator; Principal Investigator: Reza salmanyazdi, MLD, Investigator

Publications and helpful links

Helpful Links

• RoyanInstitute

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: January 17, 2011
• First Submitted That Met QC Criteria: January 18, 2011
• First Posted (Estimate): January 19, 2011

Study Record Updates

• Last Update Posted (Estimate): January 6, 2012
• Last Update Submitted That Met QC Criteria: January 5, 2012
• Last Verified: August 1, 2006

More Information

Terms related to this study

• Keywords: Metformin Acarbose pco infertility overweight
• Additional Relevant MeSH Terms: Body Weight; Overweight; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Glycoside Hydrolase Inhibitors; Metformin; Acarbose
• Other Study ID Numbers: Royan-Emb-011