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

Information source: Royan Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: PCO

Intervention: Metformin (Drug); Acarbose (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Royan Institute

Official(s) and/or principal investigator(s):
Ashraf Moini, MD, Study Chair, Affiliation: Scientific board
Elham Amirchaghmaghi, MD, Study Director, Affiliation: Invetigator
Zhila Ahmadi, BS.c, Principal Investigator, Affiliation: Investigator
Bita Eslami, MPH, Principal Investigator, Affiliation: Investigator
Ali asghar Akhlaghi, BS.c, Principal Investigator, Affiliation: Investigator
Reza salmanyazdi, MLD, Principal Investigator, Affiliation: Investigator

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

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Weight reduction (BMI improvement)

Secondary outcome:

Fasting blood sugar (FBS)

FSH

LH

Estradiol

Prolactin

Total testosterone

Total cholesterol

triglyceride

High density Lipoprotein

Low density lipoprotein

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

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

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.

Locations and Contacts

Royan Institute, Tehran, Iran, Islamic Republic of
Additional Information

RoyanInstitute

Starting date: December 2006
Last updated: January 5, 2012

Page last updated: August 23, 2015

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