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Comparison of effects of diet and exercise program to improve clinical symptoms and laboratory tests in obese women with polycystic ovary syndrome (PCOS)

Protocol summary

Summary
The aim of the study to determine the effect of diet and exercise program to improve clinical symptoms and laboratory tests of polycystic ovary syndrome women are obese. This study is randomized controlled trial and several Central. Main criteria for inclusion are being overweight, having oligomenorrhea and hirsutism. The main criteria for exclusion are having any acute or chronic medical illnesses, having diet or exercise program before the start of the study. Sample size is 50 people (25 people in experiment group and 25 people in control group). In baseline demographic data of all patients (weight, height and body mass index) and menstrual status (having or not having oligomenorrhea) and clinical characteristics of hyprandrogenisim such as hirsutism, acne, alopecia and biochemical and hormonal assessment such as fasting blood suger, Triglycerides, Cholesterol, Urea, Creatinine, complete blood cells count, Cortisol, Prolactin, total and free Testosterone levels, Estradiol, 17 Hydroxy Progesterone, Dehydroepiandrosterone Sulphate, sex hormone binding globulin, follicular stimulating hormone and Luteinized hormone will be assessed. Also abdominal ultrasound for finding of radiological characteristics of polycystic ovary syndrome for all participants will be done. Intervention plan including exercise and diet program for exprimental group run for 12 weeks and then all of these assessments within three months after the study in both groups will be repeated again. Intervention time will begin at January 2010. Evaluation of patients (for using drugs and doing diet and exercise completely) will be done by the Executive and colleagues in the study weekly.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201104032892N1
Registration date: 2011-04-03, 1390/01/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-04-03, 1390/01/14
Registrant information
Name
Mani Mirfeizi
Name of organization / entity
Islamic Azad University Karaj branch
Country
Iran (Islamic Republic of)
Phone
00982614403254/ 00982614182580/ 00982614455635
Email address
mani@kiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Islamic Azad University of karaj branch
Expected recruitment start date
2010-01-15, 1388/10/25
Expected recruitment end date
2011-07-16, 1390/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effects of diet and exercise program to improve clinical symptoms and laboratory tests in obese women with polycystic ovary syndrome (PCOS)
Public title
Effect of diet and exercise program to improve polycystic ovary syndrome (PCOS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- Participants have body mass index≥ 25 kg/ m2; 2- All Participants treat with same dose of oral contraceptives pill and spirnolacton; 3- All Participants have menstrual pattern as oligomenorrhea (irregular bleeding episodes with intervals occur more than 35 days); 4- All Participants have suffered some degree of hirsutism. Exclusion criteria: 1- Use of any drug other than the standard drug for the treatment of polycystic ovary syndrome, which is the same for everyone. (Including drugs to treat infertility, diabetes, hormonal drugs, reduce appetite and etc); 2- Smoking; 3- Being in pregnancy and lactation period or pregnancy decision; 4- Having cardiovascular, renal, liver, respiratory diseases, diabetes, uncontrolled hypertension, malignancy or any other acute or chronic disease; 5- Prohibition of the exercise due to illness or any other cause according to physician order; 6- Participating in regular exercise before the start of the study; 7- Having a separate diet programs before the start of the study.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad university Karj barnch
Street address
Crossroad of Moazen Blv and Esteghlal Blv, Rajaeeshahr, Karaj, Mailbox: 31485-313
City
Karaj
Postal code
Approval date
2010-07-18, 1389/04/27
Ethics committee reference number
002

Health conditions studied

1

Description of health condition studied
polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Endocrine, nutritional and metabolic diseases(E00-E90)

Primary outcomes

1

Description
Serum testosterone(total & free)
Timepoint
Before intervention - three months after intervention
Method of measurement
Serological test with Electro Komolomynsans method with using of the company's ROCHE kits

2

Description
serum Dehydroepiandrosterone Sulphate (DHEAS)
Timepoint
Before intervention - three months after intervention
Method of measurement
Serological test with Electro Komolomynsans method with using of the company's ROCHE kits

3

Description
Serum sex hormone binding globulin (SHBG)
Timepoint
Before intervention - three months after intervention
Method of measurement
Serological test with Electro Komolomynsans method with using of the company's ROCHE kits

4

Description
Body mass index(BMI)
Timepoint
Before intervention - three months after intervention
Method of measurement
By measuring the height (m) and weight (kg)

5

Description
hirsutism
Timepoint
Before intervention - three months after intervention
Method of measurement
Using Friedman and Galway scale

6

Description
oligomenorrhea
Timepoint
Before intervention - three months after intervention
Method of measurement
Considering the menstrual cycle (irregular bleeding episodes with intervals of more than 35 days)

7

Description
ovary status
Timepoint
Before intervention - three months after intervention
Method of measurement
using abdominal ultrasound

Secondary outcomes

1

Description
serum Progestron
Timepoint
Before intervention - three months after intervention
Method of measurement
Serological test with Electro Komolomynsans method with using of the company's ROCHE kits

2

Description
Serum LH
Timepoint
Before intervention - three months after intervention
Method of measurement
Serological test with Electro Komolomynsans method with using of the company's ROCHE kits

3

Description
serum FSH
Timepoint
Before intervention - three months after intervention
Method of measurement
Serological test with Electro Komolomynsans method with using of the company's ROCHE kits

4

Description
serum stradiol
Timepoint
Before intervention - three months after intervention
Method of measurement
Serological test with Electro Komolomynsans method with using of the company's ROCHE kits

5

Description
serum prolactin
Timepoint
Before intervention - three months after intervention
Method of measurement
Serological test with Electro Komolomynsans method with using of the company's ROCHE kits

6

Description
serum T3
Timepoint
Before intervention - three months after intervention
Method of measurement
Serological test with Electro Komolomynsans method with using of the company's ROCHE kits

7

Description
serum T4
Timepoint
Before intervention - three months after intervention
Method of measurement
Serological test with Electro Komolomynsans method with using of the company's ROCHE kits

8

Description
serum TSH
Timepoint
Before intervention - three months after intervention
Method of measurement
Serological test with Electro Komolomynsans method with using of the company's ROCHE kits

Intervention groups

1

Description
Experimental group: Diet and exercise program Diet plan: at the beginning of study a check list prepared for each individual and weekly regimen recommended separately based on feeding patterns and individual facilities. The method of regimen calculation based on total energy for each individual (TEE). We set the countable energy for reducing weight 1000 grams per week. Reduced the amount of energy and some energy into the physical activity to lose weight fraction are obtained. The combination of energy, including 40% carbohydrate, 30% fat (less than 8% saturated fatty acids was) and 30% protein is high physiological value. Fitness program: exercise sessions that included 24 meeting which duration per session was variable according to the program. For improving aerobic energy system and strengthen cardiovascular system a series exercises (slow jogging) will be used. At the beginning of the first practice sessions will be used slow intensity aerobic exercise. The first training sessions with 5 minutes of times, and 50 percent of maximum heart rate of cholera in the form alternating between resting half the time repeating the exercise. In each session we were trying to follow the principle of overload for improving cardiovascular efficiency. In higher stages (after the fifth session) of the repetition of exercises with some 60 percent of maximum heart rate is achieved. Of the ninth session, training intensity reaches to 70 percent of maximum heart rate and in last sessions with 80 percent maximum heart rate do their exercise. In each session, subjects in the first 10 minutes to warm the body and also the final 10 minutes of cooling down exercises and return to the initial state.
Category
Lifestyle

2

Description
For controls group: The standard drugs Diane: from fifth Day of cycle for 21 days every night, once a day Spironolactone: 25 mg twice a day
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrinology Clinic of Dr. Mani Mirfeizi
Full name of responsible person
Dr. Mani Mirfeizi
Street address
Omid physicians clinic, Beheshti Avenue, Karaj
City
Karaj

2

Recruitment center
Name of recruitment center
Private clinic of Dr. Sousan Kiani
Full name of responsible person
Dr. Sousan Kiani
Street address
Nilufar physicians clinic, Beheshti Avenue, Karaj
City
Karaj

3

Recruitment center
Name of recruitment center
Studies and Researches Center for Sport Sciences, Islamic Azad University of Karaj
Full name of responsible person
Dr. Shahla Hojat
Street address
Next Sabzeh Parvar Clinic, Takhti Ave, Yadegar Emam Street, Azadegan Square, Karaj
City
Karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad University of karaj branch
Full name of responsible person
Dr. Abas Ahmadi
Street address
Vice chancellor for research, Islamic Azad University of karaj branch, Crossroad of Moazen Blv and Esteghlal Blv, Rajaeeshahr, Karaj
City
Karaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Islamic Azad University of karaj branch
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
Islamic Azad University Karaj branch
Full name of responsible person
Dr. Mani Mirfeizi
Position
Professor of Internal medicine / Head of Nursing and Midwifery Karaj branch
Other areas of specialty/work
Street address
Faculity of Nursing & Midwifery, Crossroad of Moazen Blv and Esteghlal Blv, Rajaeeshahr, Karaj
City
Karaj
Postal code
Phone
00982614403254; 00982614182580; 00982614455635
Fax
Email
Mani@kiau.ac.ir; Manimirfeizi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University Karaj branch
Full name of responsible person
Dr. Mani Mirfeizi
Position
Professor of Internal medicine / Head of Nursing and Midwifery Karaj branch
Other areas of specialty/work
Street address
Faculity of Nursing & Midwifery, Crossroad of Moazen Blv and Esteghlal Blv, Rajaeeshahr, Karaj
City
Karaj
Postal code
Phone
00982614403254; 00982614182580; 00982614455635
Fax
Email
Man@kiau.ac.ir; Manimirfeizi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University Karaj branch
Full name of responsible person
Zahra Mehdizadeh Toorzani
Position
Master of midwifery
Other areas of specialty/work
Street address
Faculity of Nursing & Midwifery, Crossroad of Moazen Blv and Esteghlal Blv, Rajaeeshahr, Karaj
City
Karaj
Postal code
Phone
+98 21 3372 5785
Fax
Email
Zahramehdizade@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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