An interventional study of Carbohydrate Counting Training in Diabetes Mellitus Type 2 and Sarcopenia, sponsored by Medipol University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Medipol University · Not applicable, Interventional, and Supportive care
This study aimed to evaluate the efficacy of carbohydrate counting in individuals with type 2 diabetes receiving intensive insulin therapy. In addition, the sarcopenia status in this patient group and the effect of carbohydrate counting on sarcopenia were also evaluated.
Participants with type 2 diabetes receiving intensive insulin treatment were randomized and divided into 2 groups: education and control groups. Participants in the control group continued their standard medical and medical nutrition treatments. Participants in the training group received advanced carbohydrate counting training consisting of 3 sessions in addition to standard medical and medical nutrition therapy. The measurements of the participants in the training and control groups were repeated three times at the beginning of the study, in the 12th week and in the 24th week of the study.
A questionnaire form containing sociodemographic information was completed by face-to-face interview method. In addition, biochemical (HbA1c, fasting plasma glucose (FPG), C peptide, total cholesterol, HDL, LDL, triglyceride, estimated glomerular filtration rate) and anthropometric and body composition (weight-height, BMI, fat mass, fat ratio, muscle mass, lean tissue mass, waist circumference), hand grip strength and blood pressure measurements of the patients were taken at the beginning, 12th week and 24th week of the study.
In addition, a 24-hour retrospective food consumption record was applied to evaluate the energy and nutrient intakes. The calculation of the energy, macro and micro-nutrient intakes of the participants was carried out using the Turkish Nutrition Database Ebispro for Windows program (version 7.2)
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Exclusion Criteria:
The training group received advanced carbohydrate counting training in addition to standard medical and medical nutrition therapy.
Behavioral: Carbohydrate Counting Training
The control group continued standard medical and medical nutrition therapy only.
Advanced Carbohydrate Counting Training is a meal planning training where individuals can calculate the amount of carbohydrates in foods based on their portion sizes, and the insulin doses they need to take based on their plasma glucose levels and the amount of carbohydrates they consume.
HbA1c (%)
HbA1c levels of the participants were performed in the Biochemistry Laboratory of Fatih Sultan Mehmet Training and Research Hospital. The individuals participating in the study were asked to give blood in the morning after 10-12 hours of fasting after dinner. HbA1c levels were measured by high-performance liquid chromatography (HPLC) method. The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.
Time frame: Baseline, week 12 and week 24
Plasma Glucose Levels
Plasma glucose levels of the participants were performed in the Biochemistry Laboratory of Fatih Sultan Mehmet Training and Research Hospital. The individuals participating in the study were asked to give blood in the morning after 10-12 hours of fasting after dinner. Plasma glucose levels were analyzed by hexokinase method in colorimetric-spectrophotometric Aeroset (Roche Hitachi cobas 6000) autoanalyzer. The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.
Time frame: Baseline, week 12 and week 24
Muscle Strength
It was used for the evaluation of sarcopenia. The participants' hand grip strength was measured three times with a digital hand dynamometer (CAMRY-EH101, USA) and the mean value in kg was calculated. The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.
Time frame: Baseline, week 12, week 24
Skeletal muscle mass
It was used for the evaluation of sarcopenia. Skeletal muscle mass data obtained from the BIA measurement results and skeletal muscle according to the height obtained from this data were calculated by dividing the skeletal muscle mass by the square of the height.The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.
Time frame: Baseline, week 12, week 24
Physical performance
It was used for the evaluation of sarcopenia. In the timed walk-up test, the patient is asked to get up from the chair, walk at a normal walking speed on a flat surface of 3 meters, turn around, walk back and sit back in the chair. The time between the patient getting up from the chair, walking and sitting down again is recorded and the patient's dynamic balance during walking is also evaluated. The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.
Time frame: Baseline, week 12 and week 24
Blood lipid levels
Blood lipid levels of the participants were performed in the Biochemistry Laboratory of Fatih Sultan Mehmet Training and Research Hospital. The individuals participating in the study were asked to give blood in the morning after 10-12 hours of fasting after dinner. total cholesterol, HDL and triglyceride levels were analyzed by enzymatic colorimetric method. LDL levels were calculated using the Fridewald equation. The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.
Time frame: Baseline, week 12 and week 24
Hypoglicemia Period
It refers to the periods of hypoglycemia that individuals experience within a month. This data was asked of patients when their measurements were taken. The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.
Time frame: Baseline, week 12 and week 24
Total Insulin Dose
It is the insulin dose that individuals need to take to keep their plasma glucose levels at ideal levels during the day. This data was asked of the patients while their measurements were being taken and was verified from the patient record system in the hospital.The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.
Time frame: Baseline, week 12 and week 24
Daily Prandial Insulin
It is the insulin dose that individuals should take before meals to keep their plasma glucose levels at an ideal level during the day. This data was asked of the patients while their measurements were being taken and was verified from the patient record system in the hospital. The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.
Time frame: Baseline, week 12 and week 24
Daily Basal Insulin
It is the insulin dose that individuals need to take to keep their plasma glucose levels at ideal levels during the day. This data was asked of the patients while their measurements were being taken and was verified from the patient record system in the hospital. The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.
Time frame: Baseline, week 12 and week 24
Serum C peptide Levels
Serum C peptide levels were examined because insulin doses and carbohydrate counting were thought to affect training outcomes.Serum C peptide levels of the participants were performed in the Biochemistry Laboratory of Fatih Sultan Mehmet Training and Research Hospital. The individuals participating in the study were asked to give blood in the morning after 10-12 hours of fasting after dinner. Serum C peptide levels were determined by Enzyme-Linked Immunosorbent Assay (ELISA) method (Roche Hitachi cobas 6000) using a commercial kit in an autoanalyzer. The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.
Time frame: Baseline
Glomerular filtration rate
Glomerular filtration rate of the participants were performed in the Biochemistry Laboratory of Fatih Sultan Mehmet Training and Research Hospital. The individuals participating in the study were asked to give blood in the morning after 10-12 hours of fasting after dinner. The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.
Time frame: Baseline, week 12, week 24
Diastolic and Sistolic Blood Pressure
Blood pressure of the participants was measured with an automatic sphygmomanometer (SCIAN LD-533, Germany). Three repeated measurements were made on the right arm in the sitting position with the arm at the level of the heart and after a rest period of at least 10 minutes and the mean was calculated. The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.
Time frame: Baseline, week 12, week 24
Waist circumference
Anthropometric measurements of the participants were taken by a dietician. In waist circumference measurement, the midpoint between the bottom of the rib bone and the iliac crest was determined and the circumference of this area was measured with a tape measure. The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.
Time frame: Baseline, week 12 and week 24
Hyperglycemia period
It refers to the periods of hyperglycemia that individuals experience within a month. This data was asked of patients when their measurements were taken. The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.
Time frame: Baseline, week 12 and week 24
Food consumption (energy and nutrients intake)
A 24-hour retrospective food consumption record was applied to evaluate the energy and nutrient intakes. The calculation of the energy, macro and micro-nutrient intakes of the participants was carried out using the Turkish Nutrition Database Ebispro for Windows program (version 7.2) The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.
Time frame: Baseline, week 12 and week 24
Physical Activity Levels
The International Physical Activity Questionnaire Short Form (IPAQ-SF) was used to determine physical activity levels. The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.
Time frame: Baseline, week 12 and week 24
Height
Anthropometric measurements of the participants were taken by a dietician. The height of the participants was measured with a wall-type stadiometer with barefoot heels touching each other, arms hanging to the side, feet 45o apart and head in the Frankfort plan. The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.
Time frame: Baseline, week 12 and week 24
Body weight and body composition (fat weight, muscle weight, lean weight)
Anthropometric measurements of the participants were taken by a dietician. Body weight and body composition were measured with TANITA BC-418MA bioelectrical impedance analyzer. The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.
Time frame: Baseline, week 12 and week 24
Body Mass Index
BMI values of the participants were calculated based on weight and height measurement data. The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.
Time frame: Baseline, week 12 and week 24
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