This study is a randomized clinical trial wاich will be conducted aiming at examining the effect of DASH diet (dietary approaches to stop hypertension) on lipid profile, blood pressure, and body composition in patients aged between 18-65 suffering from diabetes type 2 who refer to Professional clinic of Urmia city within 12 weeks interventions. Those who suffer from diabetes type 2 and consume glibenclamide or metformin, and Not Suffering from any diabetic complications, will be included in this study by completing the consent form. Criteria for exclusion from the study include suffering from diabetes type 1, insulin therapy, etc.80 people are randomly selected and are then classified into 2 groups, Intervention group receiving DASH diet and control group receiving diabetic diet in accordance with the ADA (American Diabetes Association) recommendations. Blinding will be carried out for people collecting the information and perform biochemical experiments. 24-hour dietary recalls in three days (Two working days and a holiday) and analysis with N4 (nutritionist 4) software to monitor the participants diet, blood sampling to lipid profile biochemical tests, BIA (Bioelectrical impedance analysis) to body composition analysis, also international physical activity questionnaire to control the physical activity of participants in the study will be performed at the beginning and end of intervention. It will be used for the patients in case of any possible positive effect in those suffering diabetes type 2.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021432571N1
Registration date:2017-05-28, 1396/03/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-28, 1396/03/07
Registrant information
Name
Majid Manafi
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 32770698
Email address
manafi.m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
researcher (Reza Hashemi)
Expected recruitment start date
2016-01-20, 1394/10/30
Expected recruitment end date
2016-04-19, 1395/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of DASH diet on lipid profile in type 2 diabetic patients
Public title
The effect of the DASH diet in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Criteria for inclusion in the study: Suffering from diabetes type 2; Not Suffering from any diabetic complications such as nephropathy, retinopathy, neuropathy and cardiovascular complications; Aged between 18 to 65; Consumption of same drugs (glibenclamide, metformin).
Criteria for exclusion from the study: Suffering from diabetes type 1; Insulin Therapy; Suffering from liver diseases; Suffering from renal diseases; Suffering from thyroid disease; Pregnancy and lactation; Smoking and drinking alcohol; Consumption of drugs reducing blood fat and pressure and Weight, thiazide diuretics and corticosteroids; Change of type and dosage of consuming drugs during the study; Consumption of Herbal or chemical supplements; Suffering from Electrolyte abnormalities and Digestive diseases associated with malabsorption; Gastric bypass surgery and cholecystectomy.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
During the study, patients have a constant physical activity.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics Committee of Urmia University of Medical Sciences
Street address
Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road, Urmia
City
Urmia
Postal code
Approval date
2015-11-23, 1394/09/02
Ethics committee reference number
umsu.rec.1394-01-32-1919
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
Total cholesterol
Timepoint
Before Intervention and 12 weeks after Intervention
Method of measurement
enzymatic method, mg/dl
2
Description
Triglyceride
Timepoint
Before Intervention and 12 weeks after Intervention
Method of measurement
enzymatic method, mg/dl
3
Description
HDL cholesterol
Timepoint
Before Intervention and 12 weeks after Intervention
Method of measurement
enzymatic method, mg/dl
4
Description
LDL cholesterol
Timepoint
Before Intervention and 12 weeks after Intervention
Method of measurement
enzymatic method, mg/dl
5
Description
VLDL cholesterol
Timepoint
Before Intervention and 12 weeks after Intervention