Protocol summary

Summary
The aims of this interventional study are to examine the effects of energy restricted low glycemic diet on hormonal and reproductive variables of PCOS women and to compare the effects of energy restricted diet on anthropometric and metabolic characteristics between women with or without PCOS. This study will be included 30 PCOS women and 30 controls matched for BMI and age and will be recruited using convenience sampling. The case group will be recruited from PCOS women aged between 18-40 years, attending Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences. Healthy controls will be 30 age and BMI matched with PCOS women, who will be attending to the clinics of Shahid Beheshti University of Medical Sciences for annual gynecologic examinations. Sample size will be defined as 24 women in each group. Considering the loss of 20% of the subjects, 30 people will be determined for each group. For every individuals, a low energy restricted diet will be designed based on BMI of 22-23 kg/m² and a deficit of 500 kcal per day over 24 weeks. Overnight fasting venous samples will be taken for assessment of glucose, insulin SHBG and testosterone, at 0-12 and 24 weeks. Anthropometric measurements will be taken at 0-12-24 weeks. The effect of restricted energy low GI diet on hirsutism at 0-12-24 weeks and on frequency of menstrual cycles and quality of life at 0-24 weeks will be estimated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016092129909N1
Registration date: 2016-12-08, 1395/09/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-12-08, 1395/09/18
Registrant information
Name
Farnaz Shishehgar
Name of organization / entity
Reproductive Endocrinology Research Center of Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4464 4017
Email address
fshishehgar@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-10-18, 1395/07/27
Expected recruitment end date
2017-04-09, 1396/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effectiveness of interventions based on life style modification in women with polycystic ovarian syndrom
Public title
interventions based on lifestyle modification
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria Diagnosis of PCOS according to Androgen Excess Society (AES) for PCOS criteria; All of participants will be in Persian language able to read and write; Age between 18-40 years old; BMI > 25 kg / m² and < 38 kg / m²; Absence of any chronic disease; Not taking the insulin-sensitizing agents; Not taking contraceptive drugs; No special diets or exercise for weight loss in past 6 months; Not Participating in previous similar studies; Not taking ovulation induction during in the past year; Not smoking or using alcohol; Not taking antihypertensive drugs; Lack of mental disease or depression; No history of any type of malignancy Exclusion criteria: Being pregnant; Lactation in the past year; Bleeding of unknown cause
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not 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 research institute for endocrine sciences, Shahid Beheshti University of Medical
Street address
24 Parvaneh, Yaman Street, Velenjak, Tehran, I.R.Iran.
City
Tehran
Postal code
Approval date
2015-01-13, 1393/10/23
Ethics committee reference number
2ERCIES 93/10/23

Health conditions studied

1

Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E20-E35
ICD-10 code description
Disorders of other endocrine glands

Primary outcomes

1

Description
Free Androgen Index (FAI)
Timepoint
0-12-24 weeks
Method of measurement
(testosterone/SHBG *100)

2

Description
Homeostatic model assessment (Insulin resistance)
Timepoint
0-12-24 weeks
Method of measurement
[fasting insulin (mU/liter)  fasting glucose (mmol/liter)/22.5]

Secondary outcomes

1

Description
Hirsutism
Timepoint
0-12-24 weeks
Method of measurement
Ferriman-Gallwey scoring

2

Description
Menstural Cyclicity
Timepoint
0-_24 weeks
Method of measurement
Questionnare

3

Description
Waist Circumference
Timepoint
0-12-24 weeks
Method of measurement
non flexible tape measure

4

Description
Hip circumference
Timepoint
0-12-24 weeks
Method of measurement
non flexible tape measure

5

Description
Weight
Timepoint
0-12-24 weeks
Method of measurement
digital scale

6

Description
Quality of life
Timepoint
0-24 weeks
Method of measurement
Polycystic Ovary Syndrome Questionnaire (PCOSQ)

Intervention groups

1

Description
energy restricted low glycemic اindex diet
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Behesh
Full name of responsible person
Farnaz Shishehgar ( PhD in reproductive health)
Street address
24 Parvaneh, Yaman Street, Velenjak, Tehran, I.R.Iran.
City
Tehran

2

Recruitment center
Name of recruitment center
Health centers depended to the municipality( velenjak-bime- zaferanieh)
Full name of responsible person
Farnaz Shishehgar ( PhD in reproductive health)
Street address
24 Parvaneh, Yaman Street, Velenjak, Tehran, I.R.Iran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Research Institute for Endocrine Sciences, Shahid Beheshti Universit
Full name of responsible person
Doctor Azita Zadeh Vakili
Street address
24 Parvaneh, Yaman Street, Velenjak, Tehran, I.R.Iran.
City
Tehran
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 of Research Institute for Endocrine Sciences, Shahid Beheshti Universit
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
Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Behesh
Full name of responsible person
Fahimeh Ramezani Tehrani
Position
Phd, Gynecologist
Other areas of specialty/work
Street address
24 Parvaneh, Yaman Street, Velenjak, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2243 2500
Fax
Email
ramezani@endocrine.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Behesh
Full name of responsible person
Farnaz Shishehgar
Position
Phd, Reproductive Health
Other areas of specialty/work
Street address
24 Parvaneh, Yaman Street, Velenjak, Tehran, Iran.
City
Tehran
Postal code
1985717413
Phone
+98 21 2240 9309
Fax
Email
shishehgarf@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University , Tehran medical Branch
Full name of responsible person
farnaz Shishehgar
Position
PhD -Reproductive Health
Other areas of specialty/work
Street address
Tehran Medical Branch , Islamic Azad University, khaghani st, shariati Ave , Tehran, Iran
City
Tehran
Postal code
Phone
+98 212226660
Fax
Email
shishehgarf@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
empty
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