Comparing the effect of second and third generation of compound oral contraceptives on lipid and carbohydrate metabolism in overweight and obese women: a randomized clinical controlled trial
The aim of this randomized controlled trial (double blind) is comparing the effect of second and third generation of combined oral contraceptives on lipid and carbohydrate metabolism in overweight and obese women. In this study, 46 obese women and 91 overweight women aged 18 to 40 years old who are the applicants for combined oral contraceptives will be recruited. This study will be conducted at selected health care centers in Tabriz city. Eligible women will be selected through convenience sampling and will be randomly assigned into 2 groups using permuted block randomization with allocation ratio of 1:1. Random allocation sequence will be determined using a computerized program. Opaque sealed sequentially numbered envelopes from number 1 to 47 for obese women and from number 47 to 137 for overweight women will be used for allocation concealment. Intervention group will receive one Morolin tablet daily for first 21 days of each cycle and control group will receive one LD tablet daily for first 21 days of each cycle through three cycles. Main outcomes include serum levels of fasting blood glucose, total cholesterol, low density lipoprotein, high density lipoprotein after 12 hours fast and secondary outcomes include serum levels of blood glucose after 2-hour 75 gram oral glucose tolerance test and triglycerides after 12 hours fast that will be assessed by Spectrophotometric technique before the intervention and three months after intervention. The researcher and the participants will be blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402266709N15
Registration date:2014-06-14, 1393/03/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-14, 1393/03/24
Registrant information
Name
Mahnaz Shahnazi
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
mshahnazi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Tabriz University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of second and third generation of compound oral contraceptives on lipid and carbohydrate metabolism in overweight and obese women: a randomized clinical controlled trial
Public title
The effect of compound oral contraceptives tablets on lipid and carbohydrate metabolism in overweight and obese women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
married women; having regular, spontaneous menstrual cycles varying from 21 to 35 days; body mass index between 25 and 34.9 kilograms per square meter; fasting blood glucose lower than 126 milligrams per deciliter; blood glucose after 2-hour glucose tolerance test lower than 200 milligrams per deciliter; low density lipoprotein lower than 160 milligrams per deciliter; triglycerides lower than 250 milligrams per deciliter; having a desire to participate in the study
Exclusion criteria:
having absolute and relative contraindications of combined oral contraceptives; using hormonal contraceptive methods during the last 3 months; taking lipid lowering drugs such as lovastatin, Gemfibrozil, Atorvastatin, Cholestyramine, etc; having thyroid and renal diseases
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
137
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Tabriz university of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Postal code
51665118
Approval date
2014-04-28, 1393/02/08
Ethics committee reference number
9317
Health conditions studied
1
Description of health condition studied
Effect of oral contraception tablets on metabolism
ICD-10 code
Z30.4
ICD-10 code description
Surveillance of contraceptive drugs
Primary outcomes
1
Description
Fasting blood glucose
Timepoint
Before the intervention and three months after intervention
Method of measurement
Spectrophotometric technique
2
Description
Total cholesterol
Timepoint
Before the intervention and three months after intervention
Method of measurement
Spectrophotometric technique
3
Description
Low density lipoprotein
Timepoint
Before the intervention and three months after intervention
Method of measurement
Spectrophotometric technique
4
Description
High density lipoprotein
Timepoint
Before the intervention and three months after intervention
Method of measurement
Spectrophotometric technique
Secondary outcomes
1
Description
Blood glucose after 2-hour 75 gram oral glucose tolerance test
Timepoint
Before the intervention and three months after intervention
Method of measurement
Spectrophotometric technique
2
Description
Triglycerides
Timepoint
Before the intervention and three months after intervention
Method of measurement
Spectrophotometric technique
Intervention groups
1
Description
Intervention group: tablet of contraceptive DE with trade name of Marolin made by Aburaihan Pharmaceutical Company in Tehran, containing 30 micrograms Ethinyl Estradiol and 150 micrograms Desogestrel, one pill daily for first 21 days of each cycle through three cycles
Category
Prevention
2
Description
Control group: tablet of contraceptive LD with trade name of Ovocept LD made by Aburaihan Pharmaceutical Company in Tehran, containing 30 micrograms Ethinyl Estradiol and 150 micrograms Levonorgestrel, one oral pill daily for first 21 days of each cycle through three cycles
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Public health centers of Tabriz city
Full name of responsible person
Dr Mitra Yeghaneh
Street address
Tabriz Health Centre, Jahad square, Nesf-e-rah Street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Rashidi
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Samira Pourzeinali Beilankooh
Position
Master of sciences student in midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati Street, Tabriz
City
Tabriz
Postal code
5177854616
Phone
+98 41 1447 4467
Fax
Email
pourzeinalis@yahoo.com
Web page address
http://nursing.tbzmed.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Shahnazi
Position
Master of sciences of midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati Street, Tabriz
City
Tabriz
Postal code
51745347
Phone
+98 41 1479 6770
Fax
+98 41 1479 6969
Email
mshahnazi@tbzmed.ac.ir
Web page address
http://nursing.tbzmed.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samira Pourzeinali Beilankooh
Position
Master of sciences student in midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati Street, Tabriz
City
Tabriz
Postal code
5177854616
Phone
+98 41 1447 4467
Fax
Email
pourzeinalis@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)