The effect of a low calorie diet on metabolic status in normal and overweight patients with type 2 diabetes
Design
In this study, 120 patients with type 2 diabetes (۶۰ patients with normal weight and 60 patients with overweight) who were admitted to study at the endocrine clinic of Imam Khomeini Hospital in Urmia were selected.
Settings and conduct
This study will be conducted at Urmia University of Medical Sciences for 12 weeks. In this study, low calorie diet (reduction of 500 kc a day) will be given to intervention groups.
Participants/Inclusion and exclusion criteria
Criteria for inclusion in the study: normal and overweight patients with type 2 diabetes; Aged between 18 to 65; Consumption of same drugs (glibenclamide, metformin). Criteria for exclusion from the study: Suffering from liver 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 Digestive diseases associated with malabsorption; Gastric bypass surgery and cholecystectomy; Insulin Therapy; people who have been on weight loss diet or had been treated with drugs and supplements related to weight loss (such as Orlistat or Slim Last dietary supplements) in the past three months; Suffering from diabetic complications such as nephropathy, retinopathy, neuropathy and cardiovascular complications;.
Intervention groups
Normal weight diabetes patients are randomly divided into two intervention (n=30) and control (n=30) groups and overweight diabetes patients are randomly divided into two intervention (n=30) and control (n=30) groups.
Main outcome variables
Glycemic index, Lipid profile, Liver enzymes, body composition and blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170214032571N10
Registration date:2019-07-28, 1398/05/06
Registration timing:retrospective
Last update:2019-07-28, 1398/05/06
Update count:0
Registration date
2019-07-28, 1398/05/06
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
Expected recruitment start date
2018-06-21, 1397/03/31
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a low calorie diet on metabolic status in normal and overweight patients with type 2 diabetes
Public title
The effect of a low calorie diet in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Criteria for inclusion in the study:
normal and overweight patients with type 2 diabetes
Aged between 18 to 65
Consumption of same drugs (glibenclamide, metformin)
Exclusion criteria:
Criteria for exclusion from the study:
Suffering from liver 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 Digestive diseases associated with malabsorption
Gastric bypass surgery and cholecystectomy
Insulin Therapy
people who have been on weight loss diet or had been treated with drugs and supplements related to weight loss (such as Orlistat or Slim Last dietary supplements) in the past three months
Suffering from diabetic complications such as nephropathy, retinopathy, neuropathy and cardiovascular complications
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:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The volunteers were randomly assigned to intervention and control groups with normal weight and overweight, and stratified block randomization was performed based on age and sex.
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
Urmia University of Medical Sciences, orjans valley, Rresalat boulevard
Body composition analysis (Weight, Body mass index, Fat mass, Fat free mass, Visceral fat area, Waist circle, Waist to hip ratio, Skeletal muscle mass)
Timepoint
At weeks 0, 12
Method of measurement
Inbody770 Body Analyzer, Bioelectrical impedance analysis
Intervention group: Group A =Intervention in normal weight diabetes patients by reducing 500kcal of daily energy requirement for 12 months
Category
Prevention
2
Description
Intervention group: Group B = Intervention in overweight diabetes patients by reducing 500kcal of daily energy requirement for 12 months
Category
Prevention
3
Description
Control group: Group C = Normal weight diabetes patients without reducing 500kcal of daily energy requirement for 12 months
Category
Other
4
Description
Control group: Group D = Overweight diabetes patients without reducing 500kcal of daily energy requirement for 12 months
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Urmia
Full name of responsible person
Dr. Alireza Mehdizade
Street address
Floor 2, Imam Khomeini Hospital professional clinic (1), Ershad Ave
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Phone
+98 76 0132 2344
Email
majidmanafi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Iraj Mohebi
Street address
Orjhans street, Resalat Blvd, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
majidmanafi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Majid Monafi
Position
Master of Science in Nutritional Science/ Faculty Member
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Phone
+98 44 1278 0803
Email
majidmanafi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Majid Monafi
Position
Master of Science in Nutritional Science/ Faculty Member
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Phone
+98 44 1278 0803
Email
majidmanafi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Majid Manafi
Position
Master of Science in Nutritional Science/ Faculty Member
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road Urmia West Azarbijan Iran, Islamic Republic Of
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Phone
+98 44 1278 0803
Email
majidmanafi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available