1. Home
  2. Approved trials
  3. » فارسی

Comparison of the effect of low glycemic index diet and metformin drug on metabolic syndrome components in adults with metabolic syndrome

Protocol summary

Summary
Metabolic syndrome continues to be highly prevalent and contributes to a rapidly growing problem globally. The most important therapeutic intervention is diet modification; an intervention that its efficacy has been proven in metabolic syndrome. Some studies have shown that low glycemic index diet has positive effects on patients with MetS. So, the goal of this study is to compare the effects of low Glycemic Index diet and metformin drug on MetS components in order to replace the drug by the diet in adults with MetS. This study is a Randomised Controlled Clinical Trial. The inclusion criteria are the age between 25 and 65 years old and having 3 characteristics related to metabolic syndrome according to the Adult Treatment Panel, not taking any drug that might affect blood pressure and glucose, insulin or lipid metabolism, not having diabetes, liver or kidney diseases. Patients will be excluded if they get gastrointestinal disorders or lose their interest to continue the study. The 60 patients will be randomly allocated to two groups of metformin drug and low Glycemic Index diet. The intervention period is 8 weeks and at the end of the trial, the groups will be compared regarding the following factors: weight , blood pressure , waist circumference, fasting blood sugar and lipid profiles (TG, total cholesterol, LDL, HDL).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013052013399N1
Registration date: 2014-03-02, 1392/12/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-03-02, 1392/12/11
Registrant information
Name
Shirin Rajabi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
shirinrajabi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-08-24, 1392/06/02
Expected recruitment end date
2014-02-19, 1392/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of low glycemic index diet and metformin drug on metabolic syndrome components in adults with metabolic syndrome
Public title
The effect of metformin and diet on metabolic syndrome treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having 3 characteristics related to metabolic syndrome according to ATPIII ( Adult Treatment Panel): waist Circumference ≥40 (men) or ≥35 inches (women), Blood Pressure ≥135 (systole) or ≥85 (diastole) mmHg, Fasting Blood Sugar ≥100mg/dl, Triglycerides ≥150mg/dl, and High-Density Lipoproteins <40 (men) or <50 mg/dl (women). Of course the waist circumference size for Asian men is ≥90 cm and for Asian women is ≥58 cm. Not taking any drug that might affect blood pressure and glucose , insulin or lipid metabolism . Not having diabetes, liver or kidney diseases . Exclusion criteria: Patients will be excluded if they get gastrointestinal disorders or lose their interest to continue the study.
Age
From 25 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The 60 patients will randomly allocated to two group of metformin drug and low GI diet . As the patients register for entering the trial, they will be put in their own group according to their number.The method of randomization is drawing.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences.
Street address
Zand St. Shiraz
City
Shiraz
Postal code
14336 - 71348
Approval date
2013-08-04, 1392/05/13
Ethics committee reference number
CT-92-6678

Health conditions studied

1

Description of health condition studied
metabolic syndrome
ICD-10 code
E00-E90
ICD-10 code description
Endocrine, nutritional and metabolic diseases

Primary outcomes

1

Description
weight
Timepoint
before the intervention, 8weeks after the intervention
Method of measurement
seca weighing machine

2

Description
blood pressure
Timepoint
before intervention ,8weeks after intervention
Method of measurement
mmgh-piezometer

3

Description
lipid profile (TG,HDL,LDL,total Chol)
Timepoint
before intervention,8weeks after intervention
Method of measurement
biosystem autoanalyzer bt1500

4

Description
fasting blood sugar
Timepoint
before the intervention, 8 weeks after the intervention
Method of measurement
biosystem autoanalyzer bt1500

5

Description
waist circumference
Timepoint
before intervention ,8weeks after intervention
Method of measurement
centimeter-tape measure

Secondary outcomes

empty

Intervention groups

1

Description
For the diet group the percentage of required energy will be calculated with Harris-Benedict formula.The percentage of macronutrients are the same for all participants and will be 50% carbohydrate,30%fat and 20% protein.The only difference to normal diet is the use of low-GI foods in the diet plan. The foods will be chosen from Foster-Powel Table , with medium (55-70) and low ( less than 55) glycemic index.
Category
Lifestyle

2

Description
The dose of administration for the metformin group will be 500mg (1 oral tab daily) for 8 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahari Clinic
Full name of responsible person
Dr. Zohre Mazlom
Street address
Namazi Sq. Shiraz
City
Shieaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellery of Research and Technology, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali sahmoddini
Street address
Vice-Chancellery of Research and Technology,7th floor, Shiraz University of Medical Science Central Building, beside Helale-Ahmar, Zand Street, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery of Research and Technology, Shiraz 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
Nutrition Faculty
Full name of responsible person
Dr. Zohre Mazlom
Position
Associate Professor of Nutrition
Other areas of specialty/work
Street address
Nutrition Faculty, front of Bargh Stadium, Razi Blvd, Shiraz, Fars, Iran
City
Shiraz
Postal code
75541-71536
Phone
+98 71 1725 1001
Fax
Email
zohremazlom@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences, Nutrition Faculty.
Full name of responsible person
Dr.Zohre Mazlom
Position
Associate Professor of Nutrition
Other areas of specialty/work
Street address
Nutrition Faculty, front of Bargh Stadium, Razi Blvd, Shiraz, Fars, Iran
City
Shiraz
Postal code
75541-71536
Phone
+98 71 1725 1001
Fax
Email
zohremazlom@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nutrition Faculty, Shiraz University of Medical Sciences
Full name of responsible person
Shirin Rajabi
Position
MSc Student of Nutrition
Other areas of specialty/work
Street address
City
Shiraz
Postal code
7187614918
Phone
+98 71 1636 3326
Fax
Email
shirin_r69@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
Loading...