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Assessment of L-Arginine supplementation on insulin resistanc, sugar and lipid profile in patients with type II diabetes

Protocol summary

Summary
Objectives: Investigate the effect of L-Arginine supplementation on insulin resistance, sugar and lipid profile in patients with diabetes type II. Design: Randomized, double-blind, placebo-controlled study. Setting and conduct: 75 patients with type 2 diabetes were randomly selected according to eligibility criteria. Patients are randomly divided into three groups and were Followed for 90 days. Criteria for inclusion in the study: Suffering from diabetes type 2؛ Diabetes record between 4-10 years. Fasting glucose range of 160-400 mg/dl. Aged between 30 to 60. Criteria for exclusion from the study: Suffering from Renal, Liver, Parathyroid and GI Diseases. Pregnancy and lactation. Use of insulin, HbA1c<7mg/dl. Intervention: Group one: 3gr/d L-arginine; Group two: 6gr/d L-arginine and Group three placebo. main outcome measures:Height, 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: IRCT2012071010240N1
Registration date: 2014-09-24, 1393/07/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-09-24, 1393/07/02
Registrant information
Name
Sara Asadi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1624 0691
Email address
asadi@fums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences-Yazd, Iran
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2014-01-20, 1392/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of L-Arginine supplementation on insulin resistanc, sugar and lipid profile in patients with type II diabetes
Public title
Assessment of L-Arginine supplementation on insulin resistanc, sugar and lipid profile
Purpose
Supportive
Inclusion/Exclusion criteria
Criteria for inclusion in the study: Suffering from diabetes type 2؛ Diabetes record between 4-10 years. Fasting glucose range of 160-400 mg/dl. Aged between 30 to 60. Criteria for exclusion from the study: Suffering from Renal, Liver; Parathyroid and GI Diseases. Pregnancy and lactation. Use of insulin; HbA1c<7mg/dl
Age
From 40 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 75
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
Yazd Univesity of Medical Sciences Ethics Committee
Street address
Shahid Sadoughi University of Medical Sciences, Shahid Bahonar Square, Yazd.
City
Yazd
Postal code
8916978477
Approval date
2012-05-09, 1391/02/20
Ethics committee reference number
22422/1/17/پ

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
HbA1c
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
Enzyme colorimetry

2

Description
Insulin
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
Insulin kit

3

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

4

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

5

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

6

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

7

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

Secondary outcomes

1

Description
Anthropometric indicators: weight, height, body mass index, waist circumference
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
Tape and scale

2

Description
Insulin Resistance
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
HOMA index

3

Description
Insulin Sensitivity
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
HOMA2 calculator software

4

Description
Beta cell function
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
HOMA2 calculator software

Intervention groups

1

Description
3gr/d L-arginine for 3 months
Category
Treatment - Drugs

2

Description
6gr/d L-arginine for 3 months
Category
Treatment - Drugs

3

Description
3gr/d placebo for 3 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Center, Fasa University of Medical Sciences
Full name of responsible person
Dr. Seyed Javad Siadatan
Street address
Ebne Sina Square.
City
Fasa

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research, Yazd University of Medical Sciences
Full name of responsible person
Dr Hasan Mozaffari Khosravi
Street address
Shahid Bahonar Square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, Yazd 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
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Sara Asadi
Position
Graduate Student of Health Sciences in Nutrition
Other areas of specialty/work
Street address
Shahid Bahonar Square
City
Yazd
Postal code
Phone
+98 35 1624 0691
Fax
+98 35 1624 0691
Email
asadis_744@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Hasan Mozaffari Khosravi
Position
PhD of nutrition
Other areas of specialty/work
Street address
Shahid Bahonar Square.
City
Yazd
Postal code
Phone
+98 35 1624 0691
Fax
+98 35 1624 0691
Email
mozaffari@ssu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
Sara Asadi
Position
MS student of Health Sciences in Nutrition
Other areas of specialty/work
Street address
Bahonar Square
City
Yazd
Postal code
Phone
+98 35 1624 0691
Fax
+98 35 1624 0691
Email
asadis_744@yahoo.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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