Metformin Versus Acarbose Treatment in Infertile Overweight Women With Polycystic Ovary Syndrome (PCOS)
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
PCO |
Drug: Metformin Drug: Acarbose |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Metformin vs. Acarbose Treatment in Infertile Overweight Women With PCOS: A Prospective Randomized Clinical Trial |
- 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
- 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
| Enrollment: | 50 |
| Study Start Date: | December 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Genders 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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01279512
| Iran, Islamic Republic of | |
| Royan Institute | |
| Tehran, Iran, Islamic Republic of | |
| 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
Additional Information:
| Responsible Party: | Royan Institute |
| ClinicalTrials.gov Identifier: | NCT01279512 History of Changes |
| Other Study ID Numbers: | Royan-Emb-011 |
| Study First Received: | January 17, 2011 |
| Last Updated: | January 5, 2012 |
| Health Authority: | Iran: Ethics Committee Iran: Ministry of Health |
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 |
ClinicalTrials.gov processed this record on September 26, 2016