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The effects of glutamine supplementation on lipid profile, inflammatory and metabolic factors in type 2 diabetes.

Protocol summary

Summary
This randomized clinical trial is designed to determine the effects of glutamine supplementation in type 2 diabetes. 60 patients with type 2 diabetes, oral drugs lower blood sugar using and do not have liver and renal diseases between the age range of 30-65 will be randomly assigned to 2 groups that received either glutamine or placebo (3 times a day immediately prior to the meal) for 6 weeks. fast blood sugar, GLP-1, serum insulin, c- peptide, hs-CRP, REE, HDL-C, LDL-C, total cholesterol,triglycerides ,blood pressure, body composition will be measured before and 6 weekes after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201205279373N1
Registration date: 2012-08-13, 1391/05/23
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-08-13, 1391/05/23
Registrant information
Name
Asieh Mansour
Name of organization / entity
Endocrinology & Metabolism Institue,Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 919 113 8576
Email address
mansour@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Endocrinology & Metabolism Research Center Tehran University of Medical Sciences
Expected recruitment start date
2012-08-25, 1391/06/04
Expected recruitment end date
2012-11-24, 1391/09/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of glutamine supplementation on lipid profile, inflammatory and metabolic factors in type 2 diabetes.
Public title
The effects of glutamine supplementation in type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patient diagnosed with type 2 diabetes based on ADA definition or who only take oral antidiabetic drug Exclusion criteria: history of drug dependence; body mass index (BMI) ≥35 kg/m2; history of cancer; treatment with anti-inflammatory; corticosteroid; hormonal or antibiotic agents; a restrictive diet or weight change ≥ 5 kg during the 3months prior to study; systolic blood pressure >160 mmHg and/or diastolic blood pressure > 90 mmHg; fatty liver disease; liver or kidney disease; autoimmune disease; pregnancy and lactation; any change in treatment with oral hypoglycemic; anti hypertensive and antilipid agents during the study; use of weight loss medications; HbA1C >8
Age
From 30 years old to 65 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

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Ethics committees

1

Ethics committee
Name of ethics committee
Endocrinology & Metabolism Research Institute Tehran University of Medical Sciences
Street address
5th Floor,Shariati Hospital,North Kargar Ave,1411413137 Tehran Iran
City
Tehran
Postal code
Approval date
2012-07-04, 1391/04/14
Ethics committee reference number
EC-00197

Health conditions studied

1

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

Primary outcomes

1

Description
fast blood sugar
Timepoint
Before and 6 weekes after the intervention
Method of measurement
mg/ dl / enzymatic

2

Description
GLP-1 ( Glucagon- like peptide-1)
Timepoint
Before and 6 weekes after the intervention
Method of measurement
pmol/ l / ELISA

3

Description
serum insulin
Timepoint
Before and 6 weekes after the intervention
Method of measurement
pmol/ l / IRMA method

4

Description
serum c peptide
Timepoint
Before and 6 weekes after the intervention
Method of measurement
mg/ l

5

Description
Hs- CRP
Timepoint
Before and 6 weekes after the intervention
Method of measurement
ELSA

6

Description
Resting energy expenditure
Timepoint
Before and 6 weekes after the intervention
Method of measurement
indirect calorimetry

Secondary outcomes

1

Description
srum glutamine
Timepoint
Before and 6 weekes after the intervention
Method of measurement
spectrophotometric

2

Description
blood pressure
Timepoint
Before and 6 weekes after the intervention
Method of measurement
blood pressure,sphygmomanometer

3

Description
total cholestrol
Timepoint
Before and 6 weekes after the intervention
Method of measurement
mg/ dl

4

Description
HDL-C
Timepoint
Before and 6 weekes after the intervention
Method of measurement
mg/ dl

5

Description
LDL-C
Timepoint
Before and 6 weekes after the intervention
Method of measurement
mg/dl

6

Description
Hb A1C
Timepoint
Before and 6 weekes after the intervention
Method of measurement
fast HbA1c serum level,Chromatography

7

Description
serum creatinine
Timepoint
Before and 6 weekes after the intervention
Method of measurement
mg/dl

8

Description
body composition
Timepoint
Before and 6 weekes after the intervention
Method of measurement
Tanita body composition analyzer

9

Description
triglyceride
Timepoint
Before and 6 weekes after the intervention
Method of measurement
mg/dl

Intervention groups

1

Description
glutamine ( 3 times a day for 6 weeks)
Category
Treatment - Drugs

2

Description
cellulose (3 times a day for 6 weeks)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Doctor Shariati Specialized Clinic
Full name of responsible person
Saeed Hosseini
Street address
5th Floor,Shariati Hospital,North Kargar Ave,1411413137 Tehran Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Endocrinology & Metabolism Research Institute, Tehran University of Medical Sciences
Full name of responsible person
Doctor Ramin Heshmat
Street address
5th Floor,Shariati Hospital,North Kargar Ave,1411413137,Tehran,Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrinology & Metabolism Research Institute, 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
Endocrinology & Metabolism Research Institute Tehran University of Medical Sciences
Full name of responsible person
Asieh Mansour
Position
Researcher/ MSc student of nutrition.Tehran University of Medical Sciences
Other areas of specialty/work
Street address
5th Floor,Shariati Hospital,North Kargar Ave,1411413137 Tehran Iran
City
Tehran
Postal code
Phone
+882 20037
Fax
Email
asiehmansour@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Endocrinology & Metabolism Research Institute Tehran University of Medical Sciences
Full name of responsible person
Saeed Hosseini
Position
assistant professor / MD, phD
Other areas of specialty/work
Street address
5th Floor,Shariati Hospital,North Kargar Ave,1411413137 Tehran Iran
City
Tehran
Postal code
Phone
+882 200378
Fax
Email
saeedhmdphd@hotmail.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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