Comparison of the effect of metformin versus acarbose and metformin in clinical presentation and endocrinology profiles in polycystic ovarian syndrome patients
This study is a randomized double_blind clinical trial and aim is to investigate the effect of metformin versus metformin and acarbose on the clinical manifestation and endocrine/metabolic change in polycystic ovarian syndrome. inclusion criteria: age 20-45 years; women with pcos diagnosed by the rotterdam consensus criteria
Exclusion criteria: patient with systemic disease or endocrine disease; androgen secreting tumor; smokers; receiving any drug for pcos. we randomized 68 women with polycystic ovarian syndrome to rececive either tab metformin 500 mg and tab acarbose 100mg one time daily or tab metformin 500mg three times daily and tab placebo one time daily for 4 months.metabolic9f.b.s,insulin,triglycerid,cholestrol,LDL,HDL)and endocrine parameters(testosterone,DHEAS)and clinical manifestation (hirsutism,blood pressure)were evaluated before and after the intervention and data compared statitcaly.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013082214438N1
Registration date:2013-10-15, 1392/07/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-10-15, 1392/07/23
Registrant information
Name
Maryam Karimian
Name of organization / entity
Kermanshah University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6302
Email address
maryam.karimian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University Of Medical Sciences,Research Vice_Presidency
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of metformin versus acarbose and metformin in clinical presentation and endocrinology profiles in polycystic ovarian syndrome patients
Public title
Comparison of the effect of metformin versus acarbose and metformin in treatment polycystic ovarian syndrome patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 20-45 years; women with pcos diagnosed by the rotterdam consensus criteria (presence 2 of the following 3 conditions: a)oligomenorrhea /amenorrhea b)clinical or biochemical evidence of hyperandrogenism c)polycystic ovaries on sonography)
Exclusion criteria: patient with systemic disease such as cushing's syndrome; hyper or hypothyroidism; androgen secreting tumor; smokers; any systemic disease (liver ,renal,cardiovascular,diabet mellitus) ; receiving any drug for pcos such as aldacton,dian and clomiphen.
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Kermanshah University Of Medical Science and Health Servises
Street address
Shahid Beheshti Street, Kermanshah
City
Kermanshah
Postal code
Approval date
2012-12-09, 1391/09/19
Ethics committee reference number
41192
Health conditions studied
1
Description of health condition studied
polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
sclerocystic ovary syndrome
Primary outcomes
1
Description
Hirsutism
Timepoint
Before intervention - Four months after intervention
Method of measurement
Using Feriedman and Galway Scale
2
Description
Testostrone serum level
Timepoint
Before intervention - Four months after intervention
Method of measurement
Serological test with Electr Komolomynsans method
3
Description
De Hydro Epi Andrestandion serum level
Timepoint
Before intervention - Four months after intervention
Method of measurement
Serological test with Electr Komolomynsans method
4
Description
Fasting insulin serum level
Timepoint
Before intervention - Four months after intervention
Method of measurement
Elysa asses
5
Description
Fasting sugar serum level
Timepoint
Before intervention - Four months after intervention
Method of measurement
Enzyme
6
Description
Blood pressure
Timepoint
Before intervention - Four months after intervention
Method of measurement
Barometers
Secondary outcomes
1
Description
Triglycerid serum level
Timepoint
Before intervention - Four months after intervention
Method of measurement
Serological test with Electro Komolynsans method
2
Description
Cholestrol serum level
Timepoint
Before intervention - Four months after intervention
Method of measurement
Serological test with Electro Komolynsans method
3
Description
LDL serum level
Timepoint
Before intervention - Four months after intervention
Method of measurement
Serological test with Electro Komolynsans method
4
Description
HDL serum level
Timepoint
Before intervention - Four months after intervention
Method of measurement
Serological test with Electro Komolynsans method
Intervention groups
1
Description
Tab metformin 500mg three times daily,orally and tab acarbose 100mg one time daily,orally for 4months
Category
Treatment - Drugs
2
Description
Tab metformin 500mg three times daily,orally and tab placebo one time daily/orally for 4months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Maryam Karimian, MD
Street address
Sorkhelije, Kermanshah
City
Kermanshah
2
Recruitment center
Name of recruitment center
Shafa Clinic
Full name of responsible person
Nasrin Jalilian, MD
Street address
Shahrdari Street, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University Of Medical Svience, Research Vice-Presidency
Full name of responsible person
Dr. Farid Najafi
Street address
Shahid Beheshti Street, Kermanshah
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University Of Medical Svience, Research Vice-Presidency
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
kermanshah University Of Medical Science
Full name of responsible person
Maryam Karimian, MD
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Shahid Beheshti Street, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 6303
Fax
+98 83 1427 6343
Email
maryam.karimian@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University Of Medical Science
Full name of responsible person
Karoon Shahebrahimi, MD
Position
Endocrinologist
Other areas of specialty/work
Street address
Emam Reza Hospital, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
+98 83 1427 6343
Email
dr_shahebrahimi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University Of Medical Science
Full name of responsible person
Maryam Karimian, MD
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Shahid Beheshti Street, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 6303
Fax
+98 83 1427 6343
Email
maryam.karimian@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)