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

PCO Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01279512
• Other study ID #: Royan-Emb-011
• Status: Completed
• Phase: Phase 4
• First received: January 17, 2011
• Last updated: January 5, 2012
• Start date: December 2006
• Est. completion date: December 2008

Study information

• Verified date: August 2006
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Overweight
• PCO
• Polycystic Ovary Syndrome

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.
• 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).

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight reduction (BMI improvement)	compare the effect of Metformin and Acarbose to weight reduction	After 3 months of Metformin or Acarbose	Yes
Secondary	Fasting blood sugar (FBS)	Compare the effect of Metformin and acarbose to fasting blood sugar reduction	two hours post prandial blood sugar	No
Secondary	FSH	compare the effect of Metformin and Acarbose to decrease the level of FSH	6 months	No
Secondary	LH	compare the effect of Metformin and Acarbose to decrease the level of LH	6 months	No
Secondary	Estradiol	compare the effect of Metformin and Acarbose to decrease the Esteradiol level	6 months	No
Secondary	Prolactin	compare the effect of Metformin and Acarbose to decrease the Prolactin level	6 months	No
Secondary	Total testosterone	compare the the effect of Metformin and Acarbose to decrease Total testosterone level	6 months	No
Secondary	Total cholesterol	comparethe the effect of Metformin and Acarbose to decrease total cholesterol level	6 months	No
Secondary	triglyceride	comparethe the effect of Metformin and Acarbose to decrease the triglyceride level	6 months	No
Secondary	High density Lipoprotein	compare the the effect of Metformin and Acarbose to decrease high density lipoprotein	6 months	No
Secondary	Low density lipoprotein	compare the the effect of Metformin and Acarbose to decrease Low Density Lipoprotein	6 months	No

External Links

•   RoyanInstitute