(1) Objective: Determining the effect of the Mediterranean diet on blood biochemical factors in patient with diabetes under drug therapy at diabetes clinic affiliated to Golestan university of medical sciences
(2) Design: Parallel clinical trial
(3) Setting and conduct: Selecting 200 patients with type 2 diabetes referring to diabetes clinic of 5 Azar tertiary hospital affiliated to Golestan university of medical sciences and assigning them to two groups of intervention and control by simple random allocation.
(4) Participants including major eligibility criteria: Inclusion Criteria: Having type 2 diabetes; Age range between 40 to 60 years; lack of Mediterranean diet. Exclusion Criteria: Having advanced renal, liver and heart failure; Severe physical disability; Smoking.
(5) Intervention: Education of Mediterranean diet by nutritionist for 4 groups with 25 members in 2 separate sessions (8 sessions) with 2 month intervals and following- up for diet adherence by trained experts, monthly.
(6) Main outcome measures (variable): Fasting Plasma Glucose (FPG), 2-hour postprandial (2 hpp), HbA1C, and lipid profile for both intervention and control groups, before initiation of the study and after every 3 months until end of the study
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011131875N1
Registration date:2017-02-19, 1395/12/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-19, 1395/12/01
Registrant information
Name
Maryam Zahedi
Name of organization / entity
Golestan university of Medical Sciences, Gorgan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 911 177 8055
Email address
dr.zahedi-m@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Golestan University of Medical Sciences, Gorgan, Iran.
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of the Mediterranean Diet on Blood Biochemical Factors in Patients with Diabetes under Drug Therapy : a Clinical Trial
Public title
Effect of the Mediterranean Diet on Blood Biochemical Factors in Patients with Diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Having type 2 diabetes; Age range between 40 to 60 years; lack of Mediterranean diet.
Exclusion Criteria: Having advanced renal, liver and heart failure; Severe physical disability; Smoking.
Age
From 40 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
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 Golestan University of Medical Sciences
Street address
Postal code: 4934174515, Falsafi educational campus, beginning of the Shastkola road, Gorgan, Golestan province, Iran.
City
Gorgan
Postal code
Approval date
2016-04-19, 1395/01/31
Ethics committee reference number
IR. GOUMS.REC.1395.20
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
Blood biochemical Factors
Timepoint
قبل از شروع مطالعه و بعد از هر 3 ماه تا پایان مطالعه
Method of measurement
By laboratory
Secondary outcomes
1
Description
Blood pressure (BP), Body Mass Index (BMI)
Timepoint
Before initiation of the study and after every 3 months until end of the study
Method of measurement
Sphygmomanometer, Meter, and weight scale
Intervention groups
1
Description
Intervention group: Education of Mediterranean diet by nutritionist in 2 separate sessions (8 sessions, about one and half hour for each session) with 2 month intervals and Following- up for diet adherence by trained experts, monthly.
Category
Lifestyle
2
Description
Control group: there is no intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes clinic of 5 Azar tertiary hospital affiliated to Golestan university of medical sciences