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The effect of L- arginine supplementation on the lipid profile, glycemic index and insulin resistance in patients with metabolic syndrome.

Protocol summary

Summary
Objectives: This study is a double blind randomized controlled clinical trial was carried out to evaluate the effect of arginine supplementation on the lipid profile, glycemic control and measures of insulin resistance in patients with metabolic syndrome.Design: In this study, 60 patients with metabolic syndrome(Referred to Yazd Diabetes Center) will be studied With regard to the criteria for entry and exit And most of the samples for possible loss.The participants were randomly divided into two groups( intervention and placebo) And are studied for 12 weeks. Setting and conduct: The intervention group received two 2500 mg sachet arginine and placebo group received 2500 mg sachet containing cellulose compounds after lunch and dinner. main outcome measures: weight, BMI, waist circumference, HbA1c, FBS, Insulin, Insulin Sensitivity, HOMA index, HDL, TG, LDL and total cholesterol was measured before and after 3 months of intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015120425245N2
Registration date: 2015-12-30, 1394/10/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-12-30, 1394/10/09
Registrant information
Name
Davood Bahrami
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 3232 3671
Email address
davoodbahrami@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Yazd Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2015-12-01, 1394/09/10
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of L- arginine supplementation on the lipid profile, glycemic index and insulin resistance in patients with metabolic syndrome.
Public title
The effect of L- arginine supplementation on metabolic syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who agree to participate in the study؛ Having 3 or more of the ATP III criteria؛ Aged between 20 to 60. Exclusion criteria: The unwillingness of people to enter the study for any reason؛ Tobacco and alcohol؛ BMI above 35 and below 18.5؛ Pregnancy and lactationv hypersensitivity to the drug or allergy,Follow the special dietary؛ the use of insulin and Inflammatory drugs such as corticosteroids over 3 months؛ History of diabetes are more than 5 yearsv History of angina؛ stroke or heart attack in recent years؛ Chronic kidney disease or severe liver disease؛ Chronic inflammatory disease and thyroid disease during the past year؛ Taking any dietary supplement including L- arginine during 2 months before the start of the study.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences
Street address
Department of Health, Yazd Shahid Sadoughi University of Medical Sciences
City
Yazd
Postal code
8915173143
Approval date
2015-11-14, 1394/08/23
Ethics committee reference number
IR.SSU.SPH.REC.1394.53

Health conditions studied

1

Description of health condition studied
Metabolic Syndrome
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Fasting blood sugar
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
Autoanalaizer

Secondary outcomes

1

Description
HBA1C
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
Enzyme colorimetry

2

Description
total Cholesterol
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
Enzyme colorimetry

3

Description
LDL
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
Enzyme colorimetry

4

Description
HDL
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
Enzyme colorimetry

5

Description
TG
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
Enzyme colorimetry

6

Description
INSULIN
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
Enzyme colorimetry

7

Description
HOMA-IR
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
Using insulin and fasting glucose

8

Description
HOMA-B
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
Using insulin and fasting glucose

9

Description
QUICKI
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
Using insulin and fasting glucose

Intervention groups

1

Description
Intervention group: received two 2500 mg sachet arginine Production of pharmaceutical company Karen after lunch and dinner
Category
Placebo

2

Description
Control group: received 2500 mg sachet containing cellulose compounds Production of pharmaceutical company Karen after lunch and dinner
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Diabetes Research Center
Full name of responsible person
Dr Hasan Mozaffari Khosravi
Street address
Diabetes Center, Talare Honar alley, Bahonar square
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
for research of Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Hasan Mozaffari Khosravi
Street address
Department of Health, Alem square
City
Yazd
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
for research of Yazd Shahid Sadoughi 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
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Davood Bahrami
Position
Student of MSc Health Sciences in Nutrition
Other areas of specialty/work
Street address
Graduate Units,Department of Health,Shahid Sadoughi University of Medical Sciences, Hesabi Blvd
City
Yazd
Postal code
8915173143
Phone
+98 35338209114
Fax
Email
davud.bahrami@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd Shahid Sadughi University of Medical Sciences
Full name of responsible person
Hasan Mozaffari Khosravi
Position
PhD in Nutritional Sciences
Other areas of specialty/work
Street address
Graduate Units,Department of Health,Shahid Sadoughi University of Medical Sciences, Hesabi Blvd
City
Yazd
Postal code
Phone
+98 35338209114
Fax
Email
mozaffari.kh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yazd Shahid Sadughi University of Medical Sciences
Full name of responsible person
Davod Bahrami
Position
Student of MSc Health Sciences in Nutrition
Other areas of specialty/work
Street address
Graduate Units,Department of Health,Shahid Sadoughi University of Medical Sciences, Hesabi Blvd
City
Yazd
Postal code
Phone
+98 35338209114
Fax
Email
davud.bahrami@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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