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

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ClinicalTrials.gov Identifier: NCT01279512
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : January 6, 2012
Sponsor:
Information provided by (Responsible Party):
Royan Institute

Study Description
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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

Condition or disease Intervention/treatment Phase
PCO Drug: Metformin Drug: Acarbose Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Metformin vs. Acarbose Treatment in Infertile Overweight Women With PCOS: A Prospective Randomized Clinical Trial
Study Start Date : December 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources

Arms and Interventions
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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 Name: 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 Name: Acarbose description


Outcome Measures
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Primary Outcome Measures :
  1. Weight reduction (BMI improvement) [ Time Frame: After 3 months of Metformin or Acarbose ]
    compare the effect of Metformin and Acarbose to weight reduction


Secondary Outcome Measures :
  1. Fasting blood sugar (FBS) [ Time Frame: two hours post prandial blood sugar ]
    Compare the effect of Metformin and acarbose to fasting blood sugar reduction

  2. FSH [ Time Frame: 6 months ]
    compare the effect of Metformin and Acarbose to decrease the level of FSH

  3. LH [ Time Frame: 6 months ]
    compare the effect of Metformin and Acarbose to decrease the level of LH

  4. Estradiol [ Time Frame: 6 months ]
    compare the effect of Metformin and Acarbose to decrease the Esteradiol level

  5. Prolactin [ Time Frame: 6 months ]
    compare the effect of Metformin and Acarbose to decrease the Prolactin level

  6. Total testosterone [ Time Frame: 6 months ]
    compare the the effect of Metformin and Acarbose to decrease Total testosterone level

  7. Total cholesterol [ Time Frame: 6 months ]
    comparethe the effect of Metformin and Acarbose to decrease total cholesterol level

  8. triglyceride [ Time Frame: 6 months ]
    comparethe the effect of Metformin and Acarbose to decrease the triglyceride level

  9. High density Lipoprotein [ Time Frame: 6 months ]
    compare the the effect of Metformin and Acarbose to decrease high density lipoprotein

  10. Low density lipoprotein [ Time Frame: 6 months ]
    compare the the effect of Metformin and Acarbose to decrease Low Density Lipoprotein


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279512


Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
RoyanInstitute  This link exits the ClinicalTrials.gov site

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01279512     History of Changes
Other Study ID Numbers: Royan-Emb-011
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: January 6, 2012
Last Verified: August 2006

Keywords provided by Royan Institute:
Metformin Acarbose pco infertility overweight

Additional relevant MeSH terms:
Overweight
Polycystic Ovary Syndrome
Body Weight
Signs and Symptoms
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
 Gonadal Disorders
Endocrine System Diseases
Metformin
Acarbose
Hypoglycemic Agents
Physiological Effects of Drugs
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action