Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000148673
Ethics application status
Approved
Date submitted
27/01/2014
Date registered
6/02/2014
Date last updated
6/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of metformin and diet in treatment of metabolic syndrome
Scientific title
Comparison of the effect of low glycemic index diet and metformin drug on metabolic syndrome components in adults with metabolic syndrome.
Secondary ID [1] 282653 0
none
Universal Trial Number (UTN)
U1111-1144-2404
Trial acronym
-
Linked study record

Health condition
Health condition(s) or problem(s) studied:
metabolic syndrome 290222 0
Condition category
Condition code
Diet and Nutrition 290614 290614 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 291407 291407 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 60 patients will randomly allocated to two group of metformin drug and lowGI diet. The dose of administration for the metformin group will be 500mg (1 oral tab daily) for 8 weeks.
For the diet group the percentage of requiered 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 ,will medium (55-70) and low(less than 55) glycemic index.
we will make a phone call in every 2weeks for monitoring the patients. The intervention period for both groups is 8 weeks.
Intervention code [1] 288054 0
Lifestyle
Intervention code [2] 288710 0
Treatment: Drugs
Comparator / control treatment
The 60 patients will randomly allocated to two group of metformin drug and lowGI diet. there is no control group but the diet group can be consider as comparator group.
Control group
Active

Outcomes
Primary outcome [1] 290683 0
weight
method of measurement: seca scale
Timepoint [1] 290683 0
8 weeks
Primary outcome [2] 291399 0
lipid profil(TG,HDL,LDL,total Chol)
method of measurement: biosystem autoanalyzer bt1500
Timepoint [2] 291399 0
8weeks
Primary outcome [3] 291400 0
fasting blood sugre
method of measurement: biosystem autoanalyzer bt1500
Timepoint [3] 291400 0
8 weeks
Secondary outcome [1] 306580 0
none
Timepoint [1] 306580 0
none

Eligibility
Key inclusion criteria
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.
Minimum age
25 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will excluded if they get gastrointestinal disorders or not willing to continue the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The 60 patients will randomly allocated to two group of metformin drug and lowGI diet . As the patients register for entering the trial one of them goes to diet group and the other goes to metformin group respectively. The method of allocation concealment is numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using drawing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
the number of participants calculated with the related formula with these assumptions:d =8 s=10
Z 1-alph/2=1.96 Z1-beta =0.89
methods of analysis:
independent T test
Mann- whitney U test
kolomogrov-smirnov or shapiro

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/08/2013
Actual
24/08/2013
Date of last participant enrolment
Anticipated
19/02/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5776 0
Iran, Islamic Republic Of
State/province [1] 5776 0
shiraz

Funding & Sponsors
Funding source category [1] 288609 0
University
Name [1] 288609 0
Shiraz University of Medical Sciences
Country [1] 288609 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Vice-Chancellery of Research and Technology, Shiraz University of Medical Sciences
Address
Vice-Chancellery of Research and Technology,store 7th, Shiraz University of Medical Science Centeral Bulding, beside Helale-Ahmar, Zand Street,Shiraz,Fars,Iran.
postcode:14336 - 71348.
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 287319 0
None
Name [1] 287319 0
Address [1] 287319 0
Country [1] 287319 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290471 0
Ethics Committee of Shiraz University of Medical Sciences
Ethics committee address [1] 290471 0
Zand St. Shiraz, Fars.
post code:14336 - 71348
Ethics committee country [1] 290471 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 290471 0
04/08/2013
Approval date [1] 290471 0
19/08/2013
Ethics approval number [1] 290471 0
CT-92-6678

Summary
Brief summary
Metabolic syndrome continues to be highly prevalent and contributes to a rapidly growing problem globally. The most important therapeutic intervention, that its efficacy in metabolic syndrome has been proven, is diet modification. A number of studies have shown that low glycemic index diet have 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 Clinical Controlled Trial. The including criteria is the age between 25 to 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 not willing to continue the study. The 60 patients will randomly allocated to two group of metformin drug and lowGlycemic Index diet. The intervention period is 8 weeks and at the end of the trial groups will be compared for the following factors: weight , blood pressure , waist circumference, fasting blood sugar and lipid profiles (TG, total cholesterol, LDL, HDL).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40670 0
A/Prof dr zohre mazlom
Address 40670 0
shiraz university of medical sciences-nutrition faculty--front of bargh stadium- koye zahra blvd-shiraz-Fars-Iran
post code:75541-71536
Country 40670 0
Iran, Islamic Republic Of
Phone 40670 0
+987117251001
Fax 40670 0
Email 40670 0
[email protected]
Contact person for public queries
Name 40671 0
A/Prof dr zohre mazlom
Address 40671 0
dr zohre mazlom-shiraz university of medical sciences-nutrition faculty--front of bargh stadium- koye zahra blvd-shiraz-Fars-Iran
post code:75541-71536
Country 40671 0
Iran, Islamic Republic Of
Phone 40671 0
+987117251001
Fax 40671 0
Email 40671 0
[email protected]
Contact person for scientific queries
Name 40672 0
A/Prof dr zohre mazlom
Address 40672 0
shiraz university of medical sciences-nutrition faculty--front of bargh stadium- koye zahra blvd-shiraz-Fars-Iran
post code:75541-71536
Country 40672 0
Iran, Islamic Republic Of
Phone 40672 0
+987117251001
Fax 40672 0
Email 40672 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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