Diabetes Mellitus Type 2NCT07016958
Carbohydrate Counting Training in Type 2 Diabetes
A study testing Carbohydrate Counting Training in people with Diabetes Mellitus Type 2 and Sarcopenia, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2, Sarcopenia
- What is being tested?
- Carbohydrate Counting Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Uskudar Diabetes Polyclinic of the Fatih Sultan Mehmet Training and Research Hospital
Istanbul, 34672
About this study
Official 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
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.
Read the detailed description
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)
- Conditions
- Diabetes Mellitus Type 2, Sarcopenia
- Being tested
- Carbohydrate Counting Training
- Keywords
- Diabetes, carbohydrate, glycemic control, insulin, sarcopenia
- Medical subject headings
- Diabetes Mellitus, Type 2, Sarcopenia, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate Counting TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | The training group received advanced carbohydrate counting training in addition to standard medical and medical nutrition therapy. Receives: Behavioral: Carbohydrate Counting Training |
| Control Group | No intervention | The control group continued standard medical and medical nutrition therapy only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, week 12 and week 24
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, week 12 and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 Aug 2022
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two groups: training and control group.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funda GARGACI TUNCER, Medipol University
- Investigators
- Indrani KALKAN, Assoc. Prof., Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016958
- Sponsor's protocol ID
- IMU- SBE-FGT-01
- Status last verified
- Jun 2025
- First submitted
- 31 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07016958
- Acronym / sponsor ID
- IMU- SBE-FGT-01
- Conditions
- Diabetes Mellitus Type 2, Sarcopenia
- Keywords
- Diabetes, carbohydrate, glycemic control, insulin, sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are two groups: training and control group.
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Behavioral: Carbohydrate Counting TrainingThe training group received advanced carbohydrate counting training in addition to standard medical and medical nutrition therapy. |
| Control Group | No intervention | –The control group continued standard medical and medical nutrition therapy only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbohydrate Counting TrainingAdvanced 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. | Behavioural | Training Group |
Primary outcome
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.
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.
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.
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.
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.
15 secondary outcomes
Blood lipid levels
Time frame: Baseline, week 12 and week 24
Hypoglicemia Period
Time frame: Baseline, week 12 and week 24
Total Insulin Dose
Time frame: Baseline, week 12 and week 24
Daily Prandial Insulin
Time frame: Baseline, week 12 and week 24
Daily Basal Insulin
Time frame: Baseline, week 12 and week 24
Serum C peptide Levels
Time frame: Baseline
Glomerular filtration rate
Time frame: Baseline, week 12, week 24
Diastolic and Sistolic Blood Pressure
Time frame: Baseline, week 12, week 24
Waist circumference
Time frame: Baseline, week 12 and week 24
Hyperglycemia period
Time frame: Baseline, week 12 and week 24
Food consumption (energy and nutrients intake)
Time frame: Baseline, week 12 and week 24
Physical Activity Levels
Time frame: Baseline, week 12 and week 24
Height
Time frame: Baseline, week 12 and week 24
Body weight and body composition (fat weight, muscle weight, lean weight)
Time frame: Baseline, week 12 and week 24
Body Mass Index
Time frame: Baseline, week 12 and week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Indrani KALKAN, Assoc. Prof. study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate Counting Training in people with Diabetes Mellitus Type 2 and Sarcopenia, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (%) (time frame: Baseline, week 12 and week 24). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.