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The effect of Liraglutide on clinical and paraclinical symptoms in patients with polycystic ovary syndrome with high body mass index in patients referred to Shahrekord endocrinology clinics

Protocol summary

Study aim
Determining the effect of liraglutide on clinical and paraclinical symptoms in patients with polycystic ovary syndrome with high body mass index in patients referred to Shahrekord endocrinology clinics.
Design
This study is clinical trial, phase 2 which will be carried out on 35 reffering patient with polycystic ovaries with a body mass index above 25 kg/m2.
Settings and conduct
35 patients with polycystic ovary syndrome with high body mass index referred to Shahrekord endocrinological clinics, liraglutide was prescribed for three months and its effect on their clinical and paraclinical symptoms was investigated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with polycystic ovary syndrome between the ages of 18 and 45 years, giving written and oral consent to participate in the study, and not having chronic physical diseases (except for polycystic ovary syndrome) and mental diseases or long-term use of drugs according to the patient, index Body mass more than 25 kg/m2.Exclusion criteria: Smoking, suffering from other causes of hyperandrogenism such as congenital adrenal hyperplasia, Cushing's syndrome, ovarian or adrenal tumor, pregnancy, menopause, taking medications that lead to side effects such as menstrual disorders, hirsutism, or acne, and medications that affect the lipid profile or blood sugar during the last 3 months such as OCP, thiazides, hydrocortison, metformin and the like, history of previous pancreatitis and family history of medullary thyroid carcinoma (mtc)
Intervention groups
Liraglutide treated group
Main outcome variables
weight before and after the study; hair loss before and after the study; menses before and after the study; hirsutism before and after the study; Acne before and after the study; lipids before and after the study; fasting insulin before and after the study; Fasting blood sugar before and after the study

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220720055510N1
Registration date: 2022-07-30, 1401/05/08
Registration timing: prospective

Last update: 2022-07-30, 1401/05/08
Update count: 0
Registration date
2022-07-30, 1401/05/08
Registrant information
Name
Fariba Mansouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3338 3448
Email address
mansouri.fa@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-08, 1401/05/17
Expected recruitment end date
2022-10-09, 1401/07/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Liraglutide on clinical and paraclinical symptoms in patients with polycystic ovary syndrome with high body mass index in patients referred to Shahrekord endocrinology clinics
Public title
The effect of Liraglutide on clinical and paraclinical symptoms in patients with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with polycystic ovary syndrome between the ages of 18 and 45 years, Written and oral consent is obtained from patients to participate in the study Do not have chronic physical diseases (except polycystic ovary syndrome) and mental diseases. According to the patient, there is no long-term use of drugs. Body mass index is more than 25 kg/m2.
Exclusion criteria:
Smoke. suffering from other causes of hyperandrogenism such as congenital adrenal hyperplasia, Cushing's syndrome, ovarian or adrenal tumor. Taking drugs that lead to side effects such as menstrual disorders, hirsutism or acne, or affect the profile of fat or blood sugar in the last 3 months, such as OCP, thiazides, corten, metformin, etc. be pregnant. Menopause Have a history of previous pancreatitis. Have a family history of medullary thyroid carcinoma (mtc).
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of shahrekord University of Medical Sciences
Street address
shahrekord University of Medical Sciences, kashani Blvd.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2022-06-14, 1401/03/24
Ethics committee reference number
IR.SKUMS.REC.1401.056

Health conditions studied

1

Description of health condition studied
Poly cystic ovary syndrom
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
Fasting insulin
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Laboratory

2

Description
Fasting blood glucose
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Laboratory

3

Description
Menstruation
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Patient History

4

Description
hirsutism
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Ferriman-Gallwey scoring system, observation

5

Description
Acne
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Observation

6

Description
TG,HDL,LDL
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Laboratory

7

Description
Weight
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Scale

8

Description
hair loss
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Patient history

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: patients with polycystic ovary syndrome with high body mass index referred to Shahrekord endocrinology clinics who are treated with liraglutide drug under the brand name Victoza from Novonordisk pharmaceutical company. Liraglutide drug is used subcutaneously at a dose of 0.6 mg in the first week, 1.2 mg in the second week, and then 1.8 mg in the third week until the end of three months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Specialized Clinic
Full name of responsible person
Mahboube taghipour
Street address
Shariati Blvd., Imam Ali Specialized Clinic
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3224 2696
Email
imamaliclinic@skums.ac.ir
Web page address
https://imamaliclinic.skums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Zahra Habibi dastenaei
Street address
Vice-Chancellor's Office for Research, Shahr-e-Kord University of Medical Sciences, Kashani Ave.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815854459
Phone
+98 38 3352 2940
Email
habibi.z@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
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
Shahre-kord University of Medical Sciences
Full name of responsible person
Fariba mansouri
Position
Internal medicine resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Internal medicine group office, Hajar hospital, Parastar Ave.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815854459
Phone
+98 38 3352 2940
Email
Dr.f.mansouri.1393@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mahboube taghipour
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Internal medicine group office, Hajar hospital, Parastar Ave.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815854459
Phone
+98 38 3352 2940
Email
Taghipour.m@skums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Fariba mansouri
Position
Internal medicine resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Internal medicine group office, Hajar hospital, Parastar Ave.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815854459
Phone
+98 38 3352 2940
Email
Dr.f.mansouri.1393@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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