Protocol summary
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Study aim
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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 T2DM referring to Urmia Imam Khomeini hospital and Tadbir clinic
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Design
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Randomized clinical trial before and after, with an intervention group and a control group on 94 patients
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Settings and conduct
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This study is a parallel randomized controlled clinical trial in the field of investigating the effect of nutritional counseling with the approach of carbohydrate counting, glycemic index and reducing energy consumption on glycemic, lipid, anthropometric and blood pressure indicators of type 2 diabetes patients referring to Imam Khomeini Hospital and Tadbir clinic in Urmia city has been designed. 94 patients will be randomly assigned to 2 intervention and control groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Refer to Imam Khomeini hospital and Tadbir clinic 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
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Intervention groups
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The control group will receive nutritional recommendations according to the nutritional training packagein the field of health by the researcher. People in the intervention group will have 3 face-to-face 20-minute counseling sessions with the researcher on a weekly basis. The sessions will include anthropometric assessment, food intake and physical activity, familiarization with the simple carbohydrate counting method, food groups and food classification in terms of glycemic index, and diet plan.
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Main outcome variables
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Weight; Waist circumference; fasting plasma glucose; 2 hour post prandial glucose; Lipid profile; systolic blood pressure; diastolic blood pressure
General information
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Reason for update
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After the implementation of this project in August and September 1402 in the registered sampling center (Dizaj Siavosh Health Center, Urmia city), due to some problems and limitations, including the insufficient number of diabetic patients to the health center and the lack of the required sample size in the estimated period of time and the lack of cooperation and follow-up of patients with the health center, the implementation of the plan was stopped and the sampling center and the method of implementation of the plan were reviewed and edited again.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170206032417N7
Registration date:
2023-07-24, 1402/05/02
Registration timing:
prospective
Last update:
2025-05-16, 1404/02/26
Update count:
2
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Registration date
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2023-07-24, 1402/05/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-01-05, 1402/10/15
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Expected recruitment end date
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2024-07-05, 1403/04/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Investigating the effect of carbohydrate counting counseling in type 2 diabetes
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Refer to Imam khomeini educational-therapeutic center and Tadbir clinic 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
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
94
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-06-24, 1402/04/03
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Ethics committee reference number
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IR.UMSU.REC.1402.085
Health conditions studied
1
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Description of health condition studied
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Type 2 diabetes mellitus
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ICD-10 code
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E11
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ICD-10 code description
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Type 2 diabetes mellitus
Primary outcomes
1
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Description
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fasting blood sugar
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Timepoint
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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)
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Method of measurement
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Enzymatic method - international unit per liter
2
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Description
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Glycosylated hemoglobin A1c
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Timepoint
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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)
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Method of measurement
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Enzymatic method - milligrams per deciliter
3
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Description
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Waist circumference
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Timepoint
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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)
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Method of measurement
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Tape meters-centimeters
4
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Description
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Systolic blood pressure
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Timepoint
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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)
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Method of measurement
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Digital sphygmomanometer - millimeters of mercury(mmHg)
5
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Description
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Diastolic blood pressure
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Timepoint
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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)
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Method of measurement
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Digital sphygmomanometer - millimeters of mercury(mmHg)
6
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Description
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Triglyceride
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Timepoint
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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)
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Method of measurement
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Enzymatic method - milligrams per deciliter
7
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Description
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LDL-cholesterol
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Timepoint
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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)
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Method of measurement
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Enzymatic method - milligrams per deciliter
8
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Description
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HDL-cholesterol
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Timepoint
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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)
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Method of measurement
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Enzymatic method - milligrams per deciliter
9
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Description
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2 hour post prandial glucose
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Timepoint
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2 hour post prandial glucose 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)
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Method of measurement
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Enzymatic method - milligrams per deciliter
Secondary outcomes
1
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Description
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Weight
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Timepoint
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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)
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Method of measurement
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Scale-kilogram
2
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Description
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Total cholesterol
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Timepoint
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Total cholesterol measurement at the beginning of the study (before the start of the intervention) and week 16 (12 weeks after
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Method of measurement
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Enzymatic method - milligrams per deciliter
3
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Description
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Body mass index
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Timepoint
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Body mass index measurement at the beginning of the study (before the start of the intervention) and week 16 (12 weeks after
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Method of measurement
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Weight/ height squared
Intervention groups
1
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Description
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Intervention group: People in the intervention group will have 3 face-to-face 20-minute counseling sessions 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 calculated based on 25-35 kcal per body weight, is presented to the people. The diet of people with a BMI lower than 25 is isocaloric, and 250 kilocalories will be deducted from the calories of the diet of people with a BMI higher than 25. For people with a BMI above 35, the adjusted ideal body weight will be used. (Adjusted ideal body weight is calculated by adding one-fourth of the excess weight to the ideal weight. Ideal weight is calculated using the Hammwi formula.) The percentage of energy from macronutrients will be 15 to 20% of total calories for protein, depending on the protein status. Carbohydrates will be 50-55% and fat 30%. 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 get to know the 7 food groups of bread and grains, simple sugars, fruits, dairy, meat, vegetables and oils, and they will receive a list of food substitutions and an explanation of how to implement it. The third session explains about the nutritional composition table label of packaged food products and how to calculate their carbohydrate content. Also, the third session will include familiarization with the glycemic index of foods, which will be presented to people with relevant recommendations and a list of categories of foods according to their glycemic index. 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 recall will be taken from the participants by phone every month. A total of 5 food recall for 3 days with 15 days of review will be collected from the participants. Also, in order to ensure compliance with the training and 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.
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Category
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Treatment - Other
2
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Description
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Control group: People in the control group will receive a sheet of nutritional recommendations for diabetics according to the nutrition training package in the health transformation program in the field of health, by the researcher, which is a 15-minute counseling session. Until the end of the study period, a 3-day food recall (15 reminders in total) will be collected from the control group every month.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Oroumia University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available