Investigating the effect of nutrition counseling based on carbohydrate counting, glycemic index and reducing energy consumption on glycemic, lipidemic, anthropometric control indicators, and blood pressure in patients with type 2 diabetes
Determining the effect of nutritional counseling based on carbohydrate counting, glycemic profile and reducing energy consumption on glycemic, lipid, anthropometric and blood pressure control indicators of patients with type 2 diabetes referring to Urmia City Health Center
Design
Randomized clinical trial before and after, with an intervention group and a control group on 94 patients
Settings and conduct
This study is a parallel randomized controlled clinical trial in the field of investigating the effect of nutrition counseling with the approach of carbohydrate counting, glycemic index and energy consumption reduction on glycemic, lipid, anthropometric and blood pressure indicators of type 2 diabetes patients referred to Dizaj Siavosh Health Center in Urmia city. 94 patients will be randomly assigned to 2 intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Refer to Dizaj Siavosh health center in Urmia city; Having T2DM; No insulin injection;
Exclusion criteria: pregnancy and breastfeeding; Gastroparesis; Following a special diet; Consumption of nutritional supplements in the last 3 months
Intervention groups
The control group will receive the treatment of the nutrition expert of the health center according to the nutritional training package in the health transformation program in the health field. The intervention group will have 4 individual face-to-face counseling sessions of 20 minutes with the researcher on a weekly basis. Sessions will include anthropometric assessment, food intake and physical activity, familiarization with the simple carbohydrate counting method, food groups and glycemic index of foods, and diet presentation.
Investigating the effect of nutrition counseling based on carbohydrate counting, glycemic index and reducing energy consumption on glycemic, lipidemic, anthropometric control indicators, and blood pressure in patients with type 2 diabetes
Public title
Investigating the effect of carbohydrate counting counseling in type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Refer to Dizaj Siavosh health center in Urmia city
Having T2DM based on a physician's diagnosis and FPG criteria equal to and greater than 126 mg/dL and HbA1C equal to and greater than 6.5%
Age above 18 years
No insulin injection
Exclusion criteria:
Pregnancy and breastfeeding
Gastroparesis
Following a special diet
Consumption of nutritional supplements in the last 3 months
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of the samples using the Stratified Block Randomization by random allocation method based on the two variables of age and gender (use of card number 1 and also card number 2 according to the number of patients present in the study and random selection of cards) into two intervention groups and Control will be divided.
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
Research Ethics Committees of Urmia University of Medical Sciences
Street address
Resalat Blvd., emergency area, Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2023-06-24, 1402/04/03
Ethics committee reference number
IR.UMSU.REC.1402.085
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
fasting blood sugar
Timepoint
Fasting blood sugar measurement at the beginning of the study (before the start of the intervention) and 16 week of the study (12 weeks after the end of the counseling sessions of the intervention group)
Method of measurement
Enzymatic method - international unit per liter
2
Description
Glycosylated hemoglobin A1c
Timepoint
Measurement of glycosylated hemoglobin A1c at the beginning of the study (before the start of the intervention) and week 16 of the study (12 weeks after the end of the counseling sessions of the intervention group)
Method of measurement
Enzymatic method - milligrams per deciliter
3
Description
Serum insulin
Timepoint
Measurement of serum insulin at the beginning of the study (before the start of the intervention) and week 16 of the study (12 weeks after the end of the counseling sessions of the intervention group)
Method of measurement
Radioimmunoassay
4
Description
Waist circumference
Timepoint
Measurement of waist circumference at the beginning of the study (before the start of the intervention) and week 16 of the study (12 weeks after the end of the counseling sessions of the intervention group)
Method of measurement
Anthropometric meters-centimeters
5
Description
Systolic blood pressure
Timepoint
Measurement of systolic blood pressure at the beginning of the study (before the start of the intervention) and week 16 of the study (12 weeks after the end of the counseling sessions of the intervention group)
Method of measurement
Digital sphygmomanometer - millimeters of mercury(mmHg)
6
Description
Diastolic blood pressure
Timepoint
Measurement of diastolic blood pressure at the beginning of the study (before the start of the intervention) and week 16 of the study (12 weeks after the end of the counseling sessions of the intervention group)
Method of measurement
Digital sphygmomanometer - millimeters of mercury(mmHg)
7
Description
Triglyceride
Timepoint
Measurement of triglyceride at the beginning of the study (before the start of the intervention) and week 16 of the study (12 weeks after the end of the counseling sessions of the intervention group)
Method of measurement
Enzymatic method - milligrams per deciliter
8
Description
LDL-cholesterol
Timepoint
Measurement of LDL-cholesterol at the beginning of the study (before the start of the intervention) and week 16 of the study (12 weeks after the completion of the counseling sessions of the intervention group)
Method of measurement
Enzymatic method - milligrams per deciliter
9
Description
HDL-cholesterol
Timepoint
HDL-cholesterol measurement at the beginning of the study (before the start of the intervention) and the 16th week of the study (12 weeks after the end of the counseling sessions of the intervention group)
Method of measurement
Enzymatic method - milligrams per deciliter
Secondary outcomes
1
Description
Weight
Timepoint
Weight measurement at the beginning of the study (before the start of the intervention) and week 16 (12 weeks after the end of the counseling sessions of the intervention group)
Method of measurement
Scale-kilogram
2
Description
Insulin resistance index HOMA-IR
Timepoint
HOMA-IR measurement at the beginning of the study (before the start of the intervention) and week 16 (12 weeks after the end of the counseling sessions of the intervention group)
Method of measurement
Fasting sugar*fasting insulin/22.5
3
Description
Insulin sensitivity index QUICKI
Timepoint
QUICKI measurement at the beginning of the study (before the start of the intervention) and week 16 (12 weeks after the end of the counseling sessions of the intervention group)
Method of measurement
(logarithm of fasting insulin + logarithm of fasting blood sugar)/1
4
Description
Total cholesterol
Timepoint
Total cholesterol measurement at the beginning of the study (before the start of the intervention) and week 16 (12 weeks after
Method of measurement
Enzymatic method - milligrams per deciliter
5
Description
Body mass index
Timepoint
Body mass index measurement at the beginning of the study (before the start of the intervention) and week 16 (12 weeks after
Method of measurement
Weight/ height squared
Intervention groups
1
Description
Intervention group: People in the intervention group will have 4 face-to-face counseling sessions of 20 minutes with the researcher on a weekly basis. In the first session, anthropometry, food intake and physical activity are evaluated. Also, the role and importance of blood sugar control in T2DM is explained and the goals of the simple carbohydrate counting method are explained. In the second session, the diet, whose calories are estimated based on the food intake assessment by the reminder, is presented to the subjects. The diet of people with a BMI lower than 25 is isocaloric, and 250 kcal will be deducted from the calories of the diet of people with a BMI higher than 25 . The percentage of energy from macronutrients will be 55%, 15%, and 30% of total calories for carbohydrates, proteins, and fats, respectively. The amount of carbohydrates is distributed in the form of shares of different food groups containing carbohydrates in 3 main meals and 3 snacks. The number of portions is given to the patient along with examples, and the method of implementing the diet, the size of the portions, and the amount of carbohydrates are explained. In this session, patients will be introduced to the 3 food groups of bread and grains, simple sugars, and fruits, and they will receive a list of food substitutions and an explanation of how to implement it. The third session will include getting to know the food groups of dairy, meat, vegetables, and oils, and the list of food substitutions and how to implement it, the size of portions, and the amount of carbohydrates will be presented to the patients. It is also explained about the nutritional composition table label of packaged food products and how to calculate their carbohydrate content. The fourth session will be familiarization with the glycemic index of foods, where relevant recommendations and a list of foods and their glycemic index will be presented to people. In each meeting, the topics of the previous meeting are fixed and problems are solved. Until the end of the intervention period, a 3-day food reminder will be taken from the participants by phone every month. A total of 5 food reminders for 3 days with 15 days of review will be collected from the participants. Also, in order to ensure compliance with the training and to answer possible questions, people will be contacted every week, followed up and encouraged to continue working. Counseling for disabled and elderly patients or those unable to read is provided to the accompanying person.
Category
Treatment - Other
2
Description
Control group: The people in the control group will receive the common treatment of the health center by the nutrition expert based in the center according to the nutrition training package in the health transformation program in the health sector, which includes at least two 15-minute counseling sessions at a one-month interval and receiving a diet, which will record the details of the counseling and diet of the individuals. Holding meetings and receiving diet, the researcher will follow up and until the end of the study period, 3-day diet reminders (15 reminders in total) will be taken from the control group every month.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Mohammad Amin Valizadeh Hasanloui
Street address
Urmia, Resalat Blvd., Emergency valley, Headquarters of Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 4150
Email
aminvalizade@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
Dr. Mohammad Alizadeh
Position
Professor of Nutritional Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Km 11 Nazlu Highway, Urmia University of Medical Sciences, Faculty of Medicine, Department of Nutrition
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Phone
+98 44 3275 2375
Email
alizadeh.m@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Mohammad Alizadeh
Position
PhD in nutrition sciences/professor of Urmia University of Medical Sciences and faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Km 11 Nazlu Highway, Urmia University of Medical Sciences, Faculty of Medicine, Department of Nutrition
City
Urmia
Province
West Azarbaijan
Postal code
5315799313
Phone
+98 44 3275 2375
Email
alizadeh.m@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Fatemeh Pirmaddah saravani
Position
Master student of nutrition science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Km 11 Nazlu Highway, Urmia University of Medical Sciences, Faculty of Medicine, Department of Nutrition
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Phone
+98 44 3257 2357
Email
pirmaddah.fatemeh@gmail.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