Protocol summary

Summary
This study will be explored the effects of low-calorie diet on plasma levels of MIRs -33b -, 375 -‎‎, 935 and a 29 –in relation to insulin resistance, glucose and lipid metabolism in obese women ‎with type II diabetes.‎ In this randomiZed clinical trial, totally 20 obese women (BMI ≤ 45 ≥ 30 kg/m2) at the age range ‎of ‎‏ ‏‎25 to 60y, with at lest 2 years diagnosis of T2DM, without history of insulin treatment, any ‎especial diet in 6last month, liver, kidney and other metabolic diseases were recruited from the ‎out patients clinic of Emdady hospital.‎‏ ‏Patients will be divided in two groups with randomized ‎blocking method, low calorie diet and control groups. The 8-week low-calorie diet will be based ‎on the exchange list (the value obtained by subtracting 700 calories from a standard formula with ‎calculating the coefficient of outdoor activities). At the beginning and end of the study ‎questionnaires, including demographic, 3-day food recall, validated food frequency questionnaire ‎will be completed. Laboratory and anthropometric measurements measurements including FBS, ‎OGTT, serum insulin, glucagon, adiponectin, TNF-α and lipid profile, height, weight, BMI, waist ‎and hip circumference and WHR will be performed for all patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014011416223N1
Registration date: 2014-01-23, 1392/11/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-01-23, 1392/11/03
Registrant information
Name
Somayeh Mohammadi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41133575803
Email address
mohammadis.phd@gmail.com
Recruitment status
Recruitment complete
Funding source
Tabriz University of medical Sciences, Shahid beheshti University of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low calorie diet on plasma levels of miR-33b, -375, -935 and -29a, state of insulin ‎resistance and lipid metabolism in obese women with type II diabetes ‎
Public title
The effect of diet therapy as epigenetic factors in the control of diabetic complications
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria: Women with type 2 diabetes diagnosed at least two years by specialist; The ‎age range of 25 to 60; The degree of obesity in accordance with the definition of a BMI ≤ 45 ‎kg/m2 ≥ 30; Willingness to participate in research.‎ The exclusion criteria: Patients who did not complete the questionnaire; Unwillingness to blood ‎sampling; BMI over 45; Following a special diet like vegetarian diet, low calorie diet or weight-‎loss medications for obesity last year; More than three kilograms of weight change over the past ‎six months; Pregnancy, lactation, menstruation irregular; Chronic cigarette smokers (3 days more ‎than 48 months) or alcohol; Vitamin and mineral supplements; protein and phytoestrogens period ‎of 3 months prior to study entry; Taking hormonal contraceptives, anticonvulsants, ‎glucocorticoids during the recent 3 months; Patients with type 1 diabetes mellitus; Kidney ‎disease, liver disease, hyperthyroidism, a chronic inflammation (such as rheumatoid arthritis, ‎multiple sclerosis, rash, etc.) and a variety of benign and malignant masses.‎
Age
From 25 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Research vice-chancellors, Golgasht st, Azadi ave, Tabriz, Iran
City
Tabriz
Postal code
5166614711
Approval date
2013-12-16, 1392/09/25
Ethics committee reference number
5/4/8407

Health conditions studied

1

Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
micro RNA-29a
Timepoint
before and 2 month after intervention
Method of measurement
qRT-PCR, copy nomber of micro RNAs per each micro litr of plasma and deffrent percent with interior standard

2

Description
micro rna-375
Timepoint
before and 2 month after intervention
Method of measurement
qRT-PCR, copy nomber of micro RNAs per each micro litr of plasma and deffrent percent with interior standard

3

Description
micro RNA-33b
Timepoint
before and 2 month after intervention
Method of measurement
qRT-PCR, copy nomber of micro RNAs per each micro litr of plasma and deffrent percent with interior standard

4

Description
micro RNA-935
Timepoint
before and 2 month after intervention
Method of measurement
qRT-PCR, copy nomber of micro RNAs/ micro litr of plasma and deffrent percent with interior standard

5

Description
Fasting serum insulin concentration
Timepoint
before and 2 month after intervention
Method of measurement
ELISA, ‎µU/mL

6

Description
Plasma insulin concentration 2 hours after meal
Timepoint
before and 2 month after intervention
Method of measurement
ELISA, ‎µU/mL

7

Description
Serum adiponectin levels
Timepoint
before and 2 month after intervention
Method of measurement
ELISA, ng/dL

8

Description
Serum TNF-a levels
Timepoint
before and 2 month after intervention
Method of measurement
ELISA, ng/dL

9

Description
Fasting blood glucose
Timepoint
before and 2 month after intervention
Method of measurement
enzymatic colorimetric assay, mg/dL

10

Description
Blood glucose, blood glucose 2 hours after meal
Timepoint
before and 2 month after intervention
Method of measurement
enzymatic colorimetric assay, mg/dL

11

Description
Serum total cholestrol
Timepoint
before and 2 month after intervention
Method of measurement
enzymatic colorimetric assay, mg/dL

12

Description
Serum LDL-C
Timepoint
before and 2 month after intervention
Method of measurement
enzymatic colorimetric assay, mg/dL

13

Description
Serum HDL-C
Timepoint
before and 2 month after intervention
Method of measurement
enzymatic colorimetric assay, mg/dL

14

Description
Serum triglyceride level
Timepoint
before and 2 month after intervention
Method of measurement
enzymatic colorimetric assay, mg/dL

15

Description
Weight
Timepoint
before, 1 and 2 month after intervention
Method of measurement
Scale of body analyzer, Kg

16

Description
BMI
Timepoint
before, 1 and 2 month after intervention
Method of measurement
Calculating by equation, Kg/m2‎

17

Description
Waist circumference
Timepoint
before, 1 and 2 month after intervention
Method of measurement
Tape, Centimeter

18

Description
Hip circumference
Timepoint
before, 1 and 2 month after intervention
Method of measurement
Tape, Centimeter

19

Description
Waist to hip ratio
Timepoint
before, 1 and 2 month after intervention
Method of measurement
Calculating by equation, cm/cm

20

Description
Waist to height ratio
Timepoint
before, 1 and 2 month after intervention
Method of measurement
Calculating by equation, m/m

21

Description
HOMA-IR
Timepoint
before and 2 month after intervention
Method of measurement
HOMA-IR equation

22

Description
QUICKI
Timepoint
before, 1 and 2 month after intervention
Method of measurement
QUICKI equation

Secondary outcomes

1

Description
Calorie intake
Timepoint
Before, 1 month and 2 month after intervention
Method of measurement
3 day food recall and Food frequency questionnaire, Kcal/day

2

Description
Carbohdrate inake
Timepoint
Before, 1 month and 2 month after intervention
Method of measurement
3 day food recall and Food frequency questionnaire, g/day

3

Description
Protein intake
Timepoint
Before, 1 month and 2 month after intervention
Method of measurement
3 day food recall and Food frequency questionnaire, g/day

4

Description
Fat intake
Timepoint
Before, 1 month and 2 month after intervention
Method of measurement
3 day food recall and Food frequency questionnaire,g/day

Intervention groups

1

Description
Intervention group: A 8-week low calorie diet ‎‏)‏based on subtracting 700 calories from standard formula to ‎predict energy expenditure estimated at four levels of physical activity for obese women 19 years old and ‎above‏(‏‎ and planning individual diet based on exchange list.‎
Category
Treatment - Other

2

Description
Control group: without low calorie diet- Continuing with their common diet for 8-week
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Emdadi hospital
Full name of responsible person
Somayeh Mohammadi
Street address
Diabetes clinic, Emdadi Hospitsl, Transite street, Zanjan University of Medical Sciences, Abhar, Zanjan
City
Abhar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Vice-Chancellor’s Office in Research Affairs, Dr.Mohammad Reza Rashidi
Street address
Azadi street, Golgasht avenue, ,Tabriz, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice-Chancellor’s Office in Research Affairs- Dr.Afshin Zarghi
Street address
Velenjak St. , Shahid Chamran Highway, Shahid Beheshti University of Medical Sciences, 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
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
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
Tabriz University of Medical Sciences
Full name of responsible person
Somayeh Mohammadi
Position
Ph.D candidate in nutrition sciences
Other areas of specialty/work
Street address
Nutrition department, Faculty of nutrition sciences, Attar neyshabouri street, Golgasht avenue
City
Tabriz
Postal code
Phone
+98 41133575803
Fax
Email
mohammadis.phd@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Somayeh Mohammadi
Position
Ph.D candidate in nutrition sciences
Other areas of specialty/work
Street address
Public nutrition department, Faculty og nutrition sciences, Attar neyshabouri Avenue, Golgasht street
City
Tabriz
Postal code
Phone
+98 41133575803
Fax
Email
Mohammadis.phd@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Somayeh Mohammadi
Position
Ph.D candidate in Nutrition Sciences
Other areas of specialty/work
Street address
Nutrition department, Faculty of nutrition sciences, Attar neyshabouri street, Golgasht avenue
City
Tabriz
Postal code
Phone
00
Fax
Email
Mohammadis.phd@gmail.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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