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Effectiveness of Metformin in the control of weight gain related to sodium valproate administration in adults

Protocol summary

Summary
This study aimed to assess the effectiveness of metformin in the control of weight gain related to sodium valproate medication. Study population is 50 adult patients with migraine receiving sodium valproate referred to Yahyanejad Clinic who have inclusion criteria and do not have exclusion criteria. These patients will be allocated randomly in four groups. The first intervention group, included 10 persons, 500 milligram metformin (ARYA Company) in a day for twelve weeks, the second intervention group, included 10 persons, 500-1000 milligram metformin in a day for twelve weeks, and the third intervention group, included 10 persons, 1000-2000 milligram metformin in a day for twelve weeks will be prescribed. The control group, included 20 patients, will receive only education for improvement of nutrition regimen in addition to placebo. Also, nutrition improvement will be educated face-to-face in the three intervention groups. At baseline, all of the four groups will be interviewed by a psychiatrist, also, quality of life, weight, body mass index, waist circumference, blood pressure, blood sugar and lipids, renal and hepatic function will be examined. After 4, 8 and 12 weeks of metformin administration, side-effects, drug tolerance, besides weight and body mass index will be assessed. At the end of the 12th week, anthropometric measurements, blood pressure, venous blood tests and quality of life of the patients will be evaluated again.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017071322991N8
Registration date: 2017-08-16, 1396/05/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-08-16, 1396/05/25
Registrant information
Name
Sussan Moudi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 5683
Email address
sussan.mouodi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Babol University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Metformin in the control of weight gain related to sodium valproate administration in adults
Public title
Metformin for control of weight gain related to sodium valproate administration in adults
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18 to 65 years; under medication with sodium valproate for at least one month; self-reported weight gain more than three kilogram after sodium valproate administration; filling and assignment the informed consent form Exclusion criteria: diabetes in the patient; endocrine disorder in which the patient is treated with steroids; administration other psychotropic drugs except sodium valproate; suspect to polycystic ovarian disease in the patient; mental retardation or other severe physical or mental disorders which inhibit the cooperation of the patient in the research; pregnancy and breast-feeding; impairment of renal or hepatic function (creatinine or liver enzymes more than 150 percent higher than normal value); alcohol, narcotic and psychotropic drugs consumption
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz avenue
City
Babol
Postal code
Approval date
2017-06-18, 1396/03/28
Ethics committee reference number
MUBABOL.REC.1396.15

Health conditions studied

1

Description of health condition studied
Association of metformin and control of weight gain related to sodium valproate administration in adults
ICD-10 code
F99
ICD-10 code description
Unspecified mental disorder

Primary outcomes

1

Description
Weight of the patient
Timepoint
4th, 8th and 12th weeks after intervention
Method of measurement
Digital scale

2

Description
Body Mass Index
Timepoint
4th, 8th and 12th weeks after intervention
Method of measurement
Weight (kilogram) divided by squared height (meter)

Secondary outcomes

1

Description
Drug side-effects
Timepoint
4th, 8th and 12th weeks after intervention
Method of measurement
Patient visit

2

Description
Quality of life
Timepoint
12 weeks after intervention
Method of measurement
SF-36 quality of life questionnaire

Intervention groups

1

Description
Intervention group 1: 500 milligram metformin (manufactured in ARYA Company) in a day in addition to nutrition education for twelve weeks
Category
Treatment - Drugs

2

Description
Intervention group 2: 500-1000 milligram metformin (manufactured in ARYA Company) in a day in addition to nutrition education for twelve weeks
Category
Treatment - Drugs

3

Description
Intervention group 3: 1000-2000 milligram metformin (manufactured in ARYA Company) in a day in addition to nutrition education for twelve weeks
Category
Treatment - Drugs

4

Description
Control group: placebo in addition to nutrition education for twelve weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Yahyanejad Hospital
Full name of responsible person
Sussan Moudi
Street address
Yahyanejad Hospital, Babol
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Babol University of Medical Sciences
Full name of responsible person
Ali Akbar Moghadamnia, PhD
Street address
Babol University of Medical Sciences, Ganjafrooz avenue, Babol
City
Babol
Grant name
Grant code / Reference number
3513
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Babol 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
Babol University of Medical Sciences
Full name of responsible person
Sussan Moudi
Position
Assistant Professor of Psychiatry
Other areas of specialty/work
Street address
Department of Psychiatry, Yahyanejad Hospital, Babol
City
Babol
Postal code
Phone
+98 11 3219 0624
Fax
Email
sussan.mouodi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sussan Moudi
Position
Assistant Professor of Psychiatry
Other areas of specialty/work
Street address
Department of Psychiatry, Yahyanejad Hospital, Babol
City
Babol
Postal code
Phone
+98 11 3219 0624
Fax
Email
sussan.mouodi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sussan Moudi
Position
Assistant Professor of Psychiatry
Other areas of specialty/work
Street address
Department of Psychiatry, Yahyanejad Hospital, Babol
City
Babol
Postal code
Phone
+98 11 3219 0624
Fax
Email
sussan.mouodi@gmail.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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