Type of study: randomized double blind clinical trial.
Target Population: Type 2 Pre-diabetic patients that's referred to Endocrine Research Center, Shariati Hospital. The main objective of the research Effect of L-Arginine supplementation on antioxidant enzyme activity of Type 2 Pre-diabetic.
Applicable goals of the research: proposals using oral arginine to improve the health of Type 2 Pre-diabetic patients , according to a result of study
Inclusion criteria: tendency to cooperate with research project, Newly diagnosed individuals with pre-diabetes, People with pre-diabetes, a fasting blood sugar of 100 -125mg/ dL or a two-hour blood sugar between 140 to 199 mg/ dL, Range of BMI 25 to 34.9 Kg / m 2, Age: 20 to 50 years, Exclusion Criteria: - Non-compliance supplements taking (more than 10% of supplements it is not been taken .)
- The existence of any of the criteria Not allowed to inter criteria - not wanting to continued cooperation
Sample size: 46 cases (23 intervention group and 23 control)
Intervention: The intervention group patients daily 3 g L - arginine (3 capsules containing 1 g L-arginine) was given and control group intake 3 g placebo every 8 hours for 8 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211106415N2
Registration date:2013-01-02, 1391/10/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-02, 1391/10/13
Registrant information
Name
Ahmad Saedi Some Olia
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6640 2095
Email address
a_saedi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
1 - a budget that related to the to the thesis of masters degree (15,000,000) 2 -Vice chancellor for research,Tehran University of Medical Sciences
Expected recruitment start date
2012-10-31, 1391/08/10
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of L-Arginine supplementation on antioxidant enzyme activity of Type 2 Pre-diabetic patients
Public title
Effect of L-Arginine supplementation on antioxidant status in Pre-diabetic patients .
Purpose
Prevention
Inclusion/Exclusion criteria
A) Inclusion criteria:
- tendency to cooperate with research project
- Newly diagnosed individuals with pre-diabetes
- People with pre-diabetes, a fasting blood sugar of 100 -125mg/ dL or a two-hour blood sugar between 140 to 199 mg/ dL
- Range of BMI 25 to 34.9 Kg / m 2
- Age: 20 to 50 years;
B) Not allowed to inter criteria: - Have not past medical history of chronic diseases such as cardiovascular disease, liver disease, thyroid disease, chronic infection, heart attack or stroke in the previous years .- Taking lipid-lowering drugs, blood sugar-lowering drugs, estrogen or progesterone, antibiotics during past year ,- Taking any supplements such as L - arginine during the 2 months prior to the study- Smoking - pregnancy or lactation, or menopause - alcohol intake;
C) Exclusion Criteria: - Non-compliance supplements taking (more than 10% of supplements it is not been taken .)
- The existence of any of the criteria Not allowed to inter criteria - not wanting to continued cooperation
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Not 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 Tehran University of Medical Sciences
Street address
Ethics Committee of Vice chancellor for research,Tehran University of Medical Sciences, Keshavarz Blvd, Ghods st
City
Tehran
Postal code
Approval date
2012-12-03, 1391/09/13
Ethics committee reference number
91-03-161-19260-71342
Health conditions studied
1
Description of health condition studied
pre-diabetic patient
ICD-10 code
R73.0
ICD-10 code description
Impaired glucose tolerancePrediabetes
Primary outcomes
1
Description
Glutathione peroxidase activity level
Timepoint
Before and 2 months after the start of supplementation
Method of measurement
Blood testing (by ELISA kit)
2
Description
Glutathione reductase activity
Timepoint
Before and 2 months after the start of supplementation
Method of measurement
Blood testing (by ELISA kit)
3
Description
Superoxide dismutase activity
Timepoint
Before and 2 months after the start of supplementation
Method of measurement
Blood testing (by ELISA kit)
4
Description
total antioxidant capacity
Timepoint
Before and 2 months after the start of supplementation
Method of measurement
Blood testing (by ELISA kit)
Secondary outcomes
1
Description
Serum concentrations of arginine
Timepoint
Before and 2 months after supplementation
Method of measurement
blood testing
2
Description
Weight
Timepoint
Before and 2 months after supplementation
Method of measurement
Use Scale With Accuracy 100g
3
Description
height
Timepoint
Before and 2 months after supplementation
Method of measurement
Tape mete Installed on the wall
4
Description
BMI(Body Mass Index)
Timepoint
Before and 2 months after supplementation
Method of measurement
Calculation:Weight (kg) / squared height (m)
5
Description
Waist circumference
Timepoint
Before and 2 months after supplementation
Method of measurement
Tape meter
6
Description
Hip circumference
Timepoint
Before and 2 months after supplementation
Method of measurement
Tape meter
7
Description
Waist to Hip ratio
Timepoint
Before and 2 months after supplementation
Method of measurement
Calculation
8
Description
Energy intake
Timepoint
Before supplementation
Method of measurement
24 hour recall
9
Description
Carbohydrate intake
Timepoint
Before supplementation
Method of measurement
24 hour recall
10
Description
protein intake
Timepoint
Before supplementation
Method of measurement
24 hour recall
11
Description
lipid intake
Timepoint
Before supplementation
Method of measurement
24 hour recall
12
Description
Cholesterol intake
Timepoint
befor supplementation
Method of measurement
24 hours recall
13
Description
fiber intake
Timepoint
befor supplementation
Method of measurement
24hours recall
14
Description
Saturated fatty acid intake
Timepoint
Before supplementation
Method of measurement
24 hour recall
15
Description
mono unSaturated fatty acid intake
Timepoint
Before supplementation
Method of measurement
24 hour recall
16
Description
polyunsaturated fatty acids intake
Timepoint
Before supplementation
Method of measurement
24 hour recall
Intervention groups
1
Description
People with pre-diabetes, a fasting blood sugar of 100 -125mg/ dL or a two-hour blood sugar between 140 to 199 mg/ dL - Range of BMI 25 to 34.9 Kg / m 2 - Age: 20 to 50 years. daily 3 g L-arginine (3 capsules containing 1 g L-arginine) was given every 8 hours for 8 weeks.
At the end of the fourth and eighth weeks remaining capsules were counted, patients did not take their more than 10 percent of capsules, are excluded from the study. The subjects were told not to change diet and activity level.
Category
Treatment - Other
2
Description
People with pre-diabetes, a fasting blood sugar of 100 -125mg/ dL or a two-hour blood sugar between 140 to 199 mg/ dL - Range of BMI 25 to 34.9 Kg / m 2 - Age: 20 to 50 years. daily 3 g placebo(3 capsules containing 1 g Maltodextrin that was similar l-arginine) was given the same as the intervention group. The subjects were told not to change diet and activity level.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrine Research Center, Shariati Hospital
Full name of responsible person
DR Mohajerani
Street address
Endocrine Research Center, Shariati Hospital, North Kargar Avenue,, Jalal Ale Ahmad Boulevard
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tehran University of Medical Sciences
Full name of responsible person
Dr Fotouhi
Street address
Vice chancellor for research,Tehran University of Medical Sciences,The 5th floor,Ghods Street, Keshavarz Blvd , Tehran
City
Tehran
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,Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Siavash Fazelian
Position
MSc Student of Nutrition
Other areas of specialty/work
Street address
Nutrition and Biochemistry group,4th floor, Health Faculty, Poursina St, 16 Azar St, Keshavarz Blvd St, Tehran
City
Tehran
Postal code
Phone
+98 21 6640 2095
Fax
Email
siavash_nut@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Ahmad Saedi Some Olia
Position
ph.D of nutrition
Other areas of specialty/work
Street address
Nutrition and Biochemistry group,4th floor, Health Faculty, Poursina St, 16 Azar St, Keshavarz Blvd St, Tehran
City
Tehran
Postal code
Phone
+98 21 6640 2095
Fax
Email
: a_saedi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Siavash Fazelian
Position
MSc Student of Nutrition
Other areas of specialty/work
Street address
Nutrition and Biochemistry group,4th floor, Health Faculty, Poursina St, 16 Azar St, Keshavarz Blvd St, Tehran
City
Tehran
Postal code
Phone
+98 21 6640 2095
Fax
Email
siavash_nut@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)