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

Sponsor
Royan Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01279512
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
24
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
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 :
Dec 1, 2006
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Weight reduction (BMI improvement) [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) [two hours post prandial blood sugar]

      Compare the effect of Metformin and acarbose to fasting blood sugar reduction

    2. FSH [6 months]

      compare the effect of Metformin and Acarbose to decrease the level of FSH

    3. LH [6 months]

      compare the effect of Metformin and Acarbose to decrease the level of LH

    4. Estradiol [6 months]

      compare the effect of Metformin and Acarbose to decrease the Esteradiol level

    5. Prolactin [6 months]

      compare the effect of Metformin and Acarbose to decrease the Prolactin level

    6. Total testosterone [6 months]

      compare the the effect of Metformin and Acarbose to decrease Total testosterone level

    7. Total cholesterol [6 months]

      comparethe the effect of Metformin and Acarbose to decrease total cholesterol level

    8. triglyceride [6 months]

      comparethe the effect of Metformin and Acarbose to decrease the triglyceride level

    9. High density Lipoprotein [6 months]

      compare the the effect of Metformin and Acarbose to decrease high density lipoprotein

    10. Low density lipoprotein [6 months]

      compare the the effect of Metformin and Acarbose to decrease Low Density Lipoprotein

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Royan Institute
    ClinicalTrials.gov Identifier:
    NCT01279512
    Other Study ID Numbers:
    • Royan-Emb-011
    First Posted:
    Jan 19, 2011
    Last Update Posted:
    Jan 6, 2012
    Last Verified:
    Aug 1, 2006
    Keywords provided by Royan Institute
    Metformin Acarbose pco infertility overweight
    Additional relevant MeSH terms:
    Overweight
    Metformin
    Acarbose

    Study Results

    No Results Posted as of Jan 6, 2012