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

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

Overview[ - collapse ][ - ]

Purpose	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
Condition	PCO
Intervention	Drug: Metformin Drug: Acarbose
Phase	Phase 4
Sponsor	Royan Institute
Responsible Party	Royan Institute
ClinicalTrials.gov Identifier	NCT01279512
First Received	January 17, 2011
Last Updated	January 5, 2012
Last verified	August 2006

Tracking Information[ + expand ][ + ]

First Received Date	January 17, 2011
Last Updated Date	January 5, 2012
Start Date	December 2006
Estimated Primary Completion Date	December 2008
Current Primary Outcome Measures	Weight reduction (BMI improvement) [Time Frame: After 3 months of Metformin or Acarbose] [Designated as safety issue: Yes]compare the effect of Metformin and Acarbose to weight reduction
Current Secondary Outcome Measures	Fasting blood sugar (FBS) [Time Frame: two hours post prandial blood sugar] [Designated as safety issue: No]Compare the effect of Metformin and acarbose to fasting blood sugar reduction FSH [Time Frame: 6 months] [Designated as safety issue: No]compare the effect of Metformin and Acarbose to decrease the level of FSH LH [Time Frame: 6 months] [Designated as safety issue: No]compare the effect of Metformin and Acarbose to decrease the level of LH Estradiol [Time Frame: 6 months] [Designated as safety issue: No]compare the effect of Metformin and Acarbose to decrease the Esteradiol level Prolactin [Time Frame: 6 months] [Designated as safety issue: No]compare the effect of Metformin and Acarbose to decrease the Prolactin level Total testosterone [Time Frame: 6 months] [Designated as safety issue: No]compare the the effect of Metformin and Acarbose to decrease Total testosterone level Total cholesterol [Time Frame: 6 months] [Designated as safety issue: No]comparethe the effect of Metformin and Acarbose to decrease total cholesterol level triglyceride [Time Frame: 6 months] [Designated as safety issue: No]comparethe the effect of Metformin and Acarbose to decrease the triglyceride level High density Lipoprotein [Time Frame: 6 months] [Designated as safety issue: No]compare the the effect of Metformin and Acarbose to decrease high density lipoprotein Low density lipoprotein [Time Frame: 6 months] [Designated as safety issue: No]compare the the effect of Metformin and Acarbose to decrease Low Density Lipoprotein

Descriptive Information[ + expand ][ + ]

Brief Title	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
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.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Condition	PCO
Intervention	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 descriptionDrug: 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
Study Arm (s)	Experimental: Metformin reciepiants Infertile overweight women with PCO who received Metformin Experimental: Acarbose reciepiants Infertile overweight women with PCO who received Acarbose

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	50
Estimated Completion Date	December 2008
Estimated Primary Completion Date	December 2008
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.
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Iran, Islamic Republic of

Administrative Information[ + expand ][ + ]

NCT Number	NCT01279512
Other Study ID Numbers	Royan-Emb-011
Has Data Monitoring Committee	Yes
Information Provided By	Royan Institute
Study Sponsor	Royan Institute
Collaborators	Not Provided
Investigators	Study Chair: Ashraf Moini, MD Scientific boardStudy Director: Elham Amirchaghmaghi, MD InvetigatorPrincipal Investigator: Zhila Ahmadi, BS.c InvestigatorPrincipal Investigator: Bita Eslami, MPH InvestigatorPrincipal Investigator: Ali asghar Akhlaghi, BS.c InvestigatorPrincipal Investigator: Reza salmanyazdi, MLD Investigator
Verification Date	August 2006

Locations[ + expand ][ + ]