Determining the effect of aerobic exercise and DASH diet on insulin and Resistance to insulin and sex hormones in women with polycystic ovary syndrome
Design
A randomized controlled clinical trial on 60 patients who used a random number table for randomization.
Settings and conduct
60 women aged 20 to 40 years with polycystic ovary syndrome who are invited to participate in the study by a voluntary sports club.
Participants/Inclusion and exclusion criteria
1- Having at least two of the three criteria: a) low ovulation or no ovulation (which usually appears as algomenorrhea, amenorrhea, polymenorrhea) b) increase in circulating androgens, hirsutism and ratio LH / FSH> 2 and c) polycystic ovaries (seen on ultrasonography)
2- Being healthy based on health questionnaire
3- Do not take medicine
2- Not being older than 40 years and less than 20 years
3- No bmi less than .....
4- Not having more bmi than .....
5- Do not smoke
8- Do not suffer from muscle weakness related to known disorders such as stroke, cancer and cardiovascular diseases
9 - Do not use hormones and supplements as treatment
10 - Not participating in regular sports activities for at least the past year
12- Not having a separate diet outside the research program
14- Having a certificate from a doctor to perform sports exercises without hindrance
Intervention groups
Aerobic exercise (running) for 12 weeks and 3 sessions per week for 25-30 minutes and an intensity of 60-85% of maximum heart rate is observed in accordance with the principle of extra load in the gym.
DASH diet pattern:
DASH diet was used for 8 weeks and the DASH diet consisted of 52% carbohydrates, 18% protein, 30, is full fat. This diet includes a high proportion of fruits and vegetables and a minimum of fat and sugar. The recommended amount of sodium in this diet is less than 2400 mg per day.
Main outcome variables
Resistance to insulin and sex hormones
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211106052979N1
Registration date:2021-12-08, 1400/09/17
Registration timing:retrospective
Last update:2021-12-08, 1400/09/17
Update count:0
Registration date
2021-12-08, 1400/09/17
Registrant information
Name
Niusha Tajbakhsh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2276 1466
Email address
niusha.tajbakhsh.nt@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-17, 1400/07/25
Expected recruitment end date
2021-11-16, 1400/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aerobic training and DASH diet on insulin resistance and sex hormones in women with polycystic ovary syndrome
Public title
The effect of aerobic training and DASH diet on insulin resistance and sex hormones in women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
with polycystic ovary syndrome
Age 20 to 40 years
Exclusion criteria:
Doing regular exercise in the past year
Not being healthy based on a health questionnaire
Age
From 20 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)
Randomized
Randomization description
60 participants are randomly divided into 4 groups using a table of random numbers. In the present study, the restricted randomization method was used, which will be performed in a block randomization method.The size of four blocks is equal and we will have four groups of 60 blocks (including 15 people participating in each group). Randomization tool also uses software random allocation software (Random allocation software). In addition to simple randomization, these random sequence generation software are able to generate random sequences by block generation method.For concealment, we use concealment allocation, so that the assigned group is not known before the individual is assigned.Using opaque envelopes sealed with random sequences (envelopes opaque, sealed, numbered sequentially), in which each random sequence is recorded on a card. And the cards are placed in the envelopes of the letter, respectively.In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface.Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.
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
Islamic Azad University, Science and Research Branch
Street address
Tehran - End of Shahid Sattari Highway - University Square - Shohada Hesarak Boulevard - Islamic Azad University, Science and Research Branch
City
tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Approval date
2021-11-02, 1400/08/11
Ethics committee reference number
ir.iau.srb.rec.1400.179
Health conditions studied
1
Description of health condition studied
insulin resistance
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
2
Description of health condition studied
sex hormones
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Serum levels of sex hormones
Timepoint
24 hours before the intervention and 48 hours after the last session
Method of measurement
Measurement of serum LH, TSH, FSH and serum prolactin by quantitative luminescence method
2
Description
Insulin resistance
Timepoint
24 hours before the intervention and 48 hours after the last session
Method of measurement
Insulin resistance using IR-HOMA index and based on Equation * = HOMA-IR = Fasting glucose(L / mmol)* Fasting (ml / L)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Aerobic exercise (running) for 12 weeks and 3 sessions per week for 25-30 minutes and an intensity of 60-85% of maximum heart rate with the principle of extra load in the gym
Category
Treatment - Other
2
Description
Intervention group2: use of DASH diet for 8 weeks
Category
Treatment - Other
3
Description
Intervention group3: Intervention group:Aerobic exercise (running) for 12 weeks and 3 sessions per week for 25-30 minutes and an intensity of 60-85% of maximum heart rate with the principle of extra load in the gym and use of DASH diet for 8 weeks
Category
Treatment - Other
4
Description
Control group: Do not receive intervention or treatment to eliminate insulin resistance or change sex hormones
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sport Club
Full name of responsible person
Nniusha Tajbakhsh
Street address
End of Shahid Sattari Highway - University Square - Shohada Hesarak Boulevard - Islamic Azad University, Science and Research Branch
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 5179
Email
niusha.tajbakhsh.nt@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyedbabak Mozafari
Street address
End of Shahid Sattari Highway - University Square - Shohada Hesarak Boulevard - Islamic Azad University, Science and Research Branch
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 5179
Email
Mozafari@srbiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nniusha Tajbakhsh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
Tehran - Pasdaran Crossroads - Dolat St. - Between Ekhtiarieh and Dibaji - Shahid Jafarin Abadi St. - Red Dead End Alley - Sepehr Building - Unit A51
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 2276 1466
Email
niusha.tajbakhsh.nt@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Niusha Tajbakhsh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
Tehran - Pasdaran Crossroads - Dolat St. - Between Ekhtiarieh and Dibaji - Shahid Jafarin Abadi St. - Red Dead End Alley - Sepehr Building - Unit A51
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 2276 1466
Email
niusha.tajbakhsh.nt@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Niusha Tajbakhsh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
Tehran - Pasdaran Crossroads - Dolat St. - Between Ekhtiarieh and Dibaji - Shahid Jafarin Abadi St. - Red Dead End Alley - Sepehr Building - Unit A51
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 2276 1466
Email
niusha.tajbakhsh.nt@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available