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Completed

NCT Number: NCT07016958

Carbohydrate Counting Training in Type 2 Diabetes

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.

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Key information

Conditions

Diabetes Mellitus Type 2 Atrophy Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uskudar Diabetes Polyclinic of the Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34672, Turkey (Türkiye)

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A history of type 2 diabetes mellitus
  • Using insulin for more than one year
  • Being over 18 years old
  • Receiving basal and bolus insulin treatment
  • Not having received carbohydrate counting training before
  • Not receiving treatment with sulfanylurea drugs from oral anti-diabetics.

Exclusion criteria

  • Being pregnant or breastfeeding or planning a pregnancy during the study period,
  • Discontinuing insulin treatment during the study period
  • Having active proliferative retinopathy, severe nephropathy, severe or newly diagnosed cardiac disease within 6 months or stage III-IV heart failure,
  • Having dementia or psychosis and cognitive impairment,
  • Receiving glucocorticoid treatment, being fed enterally or parenterally and receiving nutrition treatment due to another/concomitant disease, having end-stage renal or hepatic/ renal disease (other than proteinuria)
  • Having liver disease/microangiopathy diseases
  • Having clinical cancer, chronic respiratory disease or amputations,
  • Having any disease or condition that would prevent completion of the study.

Treatment and study plan

Carbohydrate counting training

Behavioral

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.

Primary outcomes

  1. HbA1c (%)

    Time frame: Baseline, week 12 and week 24

    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.

  2. Plasma Glucose Levels

    Time frame: Baseline, week 12 and week 24

    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.

  3. Muscle Strength

    Time frame: Baseline, week 12, week 24

    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.

  4. Skeletal muscle mass

    Time frame: Baseline, week 12, week 24

    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.

  5. Physical performance

    Time frame: Baseline, week 12 and week 24

    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.

Secondary outcomes

  1. Blood lipid levels

    Time frame: Baseline, week 12 and week 24

    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.

  2. Hypoglicemia Period

    Time frame: Baseline, week 12 and week 24

    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.

  3. Total Insulin Dose

    Time frame: Baseline, week 12 and week 24

    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.

  4. Daily Prandial Insulin

    Time frame: Baseline, week 12 and week 24

    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.

  5. Daily Basal Insulin

    Time frame: Baseline, week 12 and week 24

    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.

  6. Serum C peptide Levels

    Time frame: Baseline

    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.

  7. Glomerular filtration rate

    Time frame: Baseline, week 12, week 24

    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.

  8. Diastolic and Sistolic Blood Pressure

    Time frame: Baseline, week 12, week 24

    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.

  9. Waist circumference

    Time frame: Baseline, week 12 and week 24

    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.

  10. Hyperglycemia period

    Time frame: Baseline, week 12 and week 24

    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.

  11. Food consumption (energy and nutrients intake)

    Time frame: Baseline, week 12 and week 24

    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.

  12. Physical Activity Levels

    Time frame: Baseline, week 12 and week 24

    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.

  13. Height

    Time frame: Baseline, week 12 and week 24

    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.

  14. Body weight and body composition (fat weight, muscle weight, lean weight)

    Time frame: Baseline, week 12 and week 24

    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.

  15. Body Mass Index

    Time frame: Baseline, week 12 and week 24

    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.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

Effects of Carbohydrate Counting Training Versus Standard Nutritional and Medical Therapy on Glycemic Control and Sarcopenia in Type 2 Diabetes: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 12, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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