Protocol summary

Summary
In this study for the first time we evaluate the effects of dietary energy reduction and increase fiber intake to individuals with polymorphisms T-C 256- APOAII. This study is a non-randomized, not blinded and without placebo that is done on 56 patients with type II diabetes. Diabetic samples will elect from 800 samples which has been collected in the previous study and took in two groups of CC genotype and T allele carrier group includes TT or TC. Of these, 28 patients with CC genotype are selected. Inclusion criteria are an age range between 45 to 65 years, BMI greater than or equal to 27 and any injection of insulin. Exclusion criteria consist of use of tobacco and alcohol, patients with chronic inflammatory diseases and use of Anti-inflammatory medications or multivitamin and mineral supplements. The t allele carrier group will be homologized in terms of gender, receiving lipid-lowering drugs, BMI and age with CC group. Patients will receive low-energy diet( 500-1000 calorie less than their needs), rich in fiber (30 grams per day) during 6 weeks. Blood samples will be taken before the study and at the end of the intervention and the levels of certain serum factors such as TNF-α, NFKB, ICAM1, VCAM1 and HDL2 and HDL3 and enzyme LCAT, PON1, PON3 and their relationship with APOA-I and APOA-II we will study. The gene expression of PTX3, VCAM1, ICAM1 will be measured.

General information

Acronym
apoa2=apolipoprotein a2
IRCT registration information
IRCT registration number: IRCT2015071323195N1
Registration date: 2015-10-22, 1394/07/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-10-22, 1394/07/30
Registrant information
Name
Masoumeh Moradi
Name of organization / entity
Tehran University of Medical Sciences, School of Nutritional Science and Ditetics
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5568
Email address
m_moradi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences International Campus
Expected recruitment start date
2015-10-12, 1394/07/20
Expected recruitment end date
2016-01-10, 1394/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
clinical trial of calorie restriction with medium fiber diet on serum levels of some inflammatory factors and their gene expression in obese and overweight type 2 diabetic patients with CC and TT/TC polymorphism in APOA-II and comparison of changes in these genotypes
Public title
the effect of calorie restriction with medium fiber diet in obese and overweight type 2 diabetic patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: age between 45-65 years; BMI more than or equal 27; type 2 diabetes who do not inject insulin Exclusion criteria: compliance of dietary recommendations less than 80%; Acute inflammatory diseases in the last 3 days before blood sampling; receiving antiinflammatory medications and multivitamin mineral supplements during the intervention
Age
From 49 years old to 29 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 28
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not 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
Poorsina Avenue, Ghods Street, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2015-09-21, 1394/06/30
Ethics committee reference number
IR.TUMS.REC.1394.805

Health conditions studied

1

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

2

Description of health condition studied
obesity
ICD-10 code
E66
ICD-10 code description
Obesity

Primary outcomes

1

Description
paraoxonase 1 enzyme
Timepoint
before and after intervention
Method of measurement
kit

2

Description
activity of LCAT enzyme
Timepoint
before and after intervention
Method of measurement
kit

3

Description
serum TNF-α
Timepoint
before and after intervention
Method of measurement
kit

4

Description
VCAM1, ICAM1, PTX3 gene expression
Timepoint
before and after intervention
Method of measurement
Real-Time PCR

5

Description
paraoxonase3 enzyme
Timepoint
before and after intervention
Method of measurement
kit

6

Description
serum NFKB
Timepoint
before and after intervention
Method of measurement
kit

7

Description
serum ICAM1
Timepoint
before and after intervention
Method of measurement
kit

8

Description
serum VCAM1
Timepoint
before and after intervention
Method of measurement
kit

9

Description
serum HDL2 and HDL3
Timepoint
before and after intervention
Method of measurement
kit

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
During a 6-week patients will receive low-energy diet and moderate fiber (30 grams per day) including 55 to 65% carbohydrates, 20% protein and 25% fat. To get enough fiber in addition to increasing the consumption of fruits and vegetables will add wheat bran to the diet and to ensure the same type of bran consumption the required amount will be available to them every two weeks. After calculating the amount of energy needed for daily, diets will be set for each individual. 21 food menu with identified calorie will prepare for each personand every two weeks we will give them 7 menu with same calorie to the individuals which give them the power to choose the desired menu and even have a repeat in the week. And they also share the same energy that allows people to use between meals, such as breakfast menu to choose their favorite
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran University School of Public Health Laboratories
Full name of responsible person
Mr. Ehsan Alvandi
Street address
Poorsina Avenue, Ghods Street, Keshavarz Blvd.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences International Campus, School of Nutritional Science and Diteti
Full name of responsible person
Mrs. Dr. Fariba Kuhdani
Street address
Number 44, Hojatdoost Avenue, Naderi Street, Keshavarz Blvd.
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences International Campus, School of Nutritional Science and Diteti
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, School of Nutritional Science and Ditetics
Full name of responsible person
Masoumeh Moradi
Position
ph.D student
Other areas of specialty/work
Street address
Number 44, Hojatdust Avenue, Naderi Street, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 4473 3292
Fax
Email
moradi_ma@yahoo.com;m_moradi@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences, School of Nutritional Science and Ditetics
Full name of responsible person
Dr. Fariba Koohdani
Position
research assistant
Other areas of specialty/work
Street address
Number 44, Hojatdust avenue, Naderi Street, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 8895 5569
Fax
Email
fkoohdan@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences, School of Nutritional Science and Ditetics
Full name of responsible person
Masoumeh Moradi
Position
ph.D student of nutrition
Other areas of specialty/work
Street address
Number 44, Hojatdoost Avenue, Naderi Street, Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 44733292
Fax
Email
moradi_ma@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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