PrediabetesCARB-PREDNCT07525622
Basic Carbohydrate Counting in Prediabetes
A study testing Carbohydrate Couinting-Based Nutrition Education in people with Prediabetes, run by Hamide Sahin at 1 site in Turkey (Türkiye).
Trial summary
Type 2 diabetes mellitus (T2DM) is a major global health problem with rapidly increasing prevalence. Prediabetes represents a high-risk state for developing T2DM and is often asymptomatic, delaying diagnosis and intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prediabetes
- What is being tested?
- Carbohydrate Couinting-Based Nutrition Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Apr 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults aged 18 years and older
- Able to read and write Individuals with prediabetes who are not using or are unwilling to initiate oral antidiabetic drugs.
Who cannot join
- Individuals with a diagnosis of diabetes mellitus
- Those who have previously received carbohydrate counting training or are currently applying carbohydrate counting
- Individuals with low daily carbohydrate intake (<100 g/day)
- Presence of uncontrolled medical conditions that may affect dietary intake, as determined by the investigator
- Pregnant or breastfeeding women, or those planning pregnancy during the study period
- Participation in another clinical study Inability or unwillingness to provide informed consent or comply with study procedures
- Cognitive impairment or communication difficulties (hearing, understanding, or speaking)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University Hospital
Istanbul, Pendik, 34000
Hamide Vural, MD, +905554907224, hamidesahin92@gmail.com
About this study
Official title: The Effect of Basic Carbohydrate Counting on HbA1c in Prediabetes: A Randomized Controlled Trial
Type 2 diabetes mellitus (T2DM) is a major global health problem with rapidly increasing prevalence. Prediabetes represents a high-risk state for developing T2DM and is often asymptomatic, delaying diagnosis and intervention. Early identification and effective lifestyle interventions are essential to prevent or delay the progression to diabetes. Primary care settings provide an important opportunity for screening and implementing preventive strategies.
Lifestyle modification, including dietary changes and physical activity, is the cornerstone of diabetes prevention. Carbohydrate counting is a medical nutrition therapy widely used in diabetes management and has been shown to improve glycemic control. However, there is limited evidence regarding its effectiveness in individuals with prediabetes.
Read more
This study aims to evaluate the effect of basic carbohydrate counting education on HbA1c levels in individuals with prediabetes in a primary care setting.
This randomized controlled trial will be conducted in the Family Medicine outpatient clinic of Marmara University Hospital. Individuals aged 18 years and older with HbA1c levels between 5.7% and 6.4% will be included. Participants will be randomized into intervention and control groups in a 2:1 ratio.
The control group will receive standard lifestyle recommendations, while the intervention group will receive additional structured basic carbohydrate counting education in three sessions. HbA1c levels will be measured at baseline,at third and at 6 months. Secondary outcomes include body weight, body mass index, waist circumference,lipid panel and carbohydarte counting knowledge scale The findings of this study are expected to contribute to the development of effective, scalable, and practical nutritional interventions for diabetes prevention in primary care
Read the detailed description
Type 2 diabetes mellitus (T2DM) is a major and rapidly growing global health problem. Prediabetes represents a high-risk state for progression to T2DM and provides a critical window for preventive interventions. Since prediabetes is often asymptomatic, early detection and effective lifestyle-based strategies are essential. Primary care settings offer an optimal environment for identifying high-risk individuals and implementing preventive interventions.
Lifestyle modification, particularly dietary interventions and physical activity, is the cornerstone of diabetes prevention. Medical nutrition therapy (MNT) has been shown to play a key role in improving glycemic outcomes. Basic carbohydrate counting (CC), as a component of MNT, is a practical and structured dietary approach aimed at increasing awareness of carbohydrate intake and improving glycemic control. However, evidence regarding its effectiveness in individuals with prediabetes remains limited.
This study aims to evaluate the effect of basic carbohydrate counting education on HbA1c levels in individuals with prediabetes in a primary care setting.
This study will be designed as a randomized controlled trial conducted at the Family Medicine outpatient clinic of Marmara University Hospital. Adults aged 18 years and older with HbA1c levels between 5.7% and 6.4% who meet the inclusion criteria and provide informed consent will be enrolled.
Participants will be randomized into intervention and control groups using a simple randomization method in a 2:1 ratio. All participants will receive standard lifestyle recommendations as part of usual care. Additionally, a booklet including information on healthy nutrition and basic carbohydrate counting, prepared based on current scientific literature, will be provided to all participants.
At baseline, all participants will complete a questionnaire assessing sociodemographic characteristics and diabetes-related factors. The "Nutrition and Basic Carbohydrate Counting Knowledge Scale" will be administered at baseline, 3 months, and 6 months. This scale consists of 20 items, including true/false statements and two fill-in-the-blank questions related to fasting and postprandial blood glucose.
Anthropometric measurements including body weight, body mass index (BMI), and waist circumference (WC) will be recorded at baseline, 3 months, and 6 months. Laboratory assessments including HbA1c, fasting blood glucose (FBG), and lipid profile will also be performed at the same time points.
Participants in the intervention group will receive structured basic carbohydrate counting education delivered in three sessions at one-week intervals, each lasting 30-45 minutes. The training program will be developed in collaboration with a dietitian. Participants in the intervention group will also be asked to complete 3-day dietary records before each training session.
Following the training sessions, participants in the intervention group will be followed up with monthly telephone calls. During these follow-ups, adherence to the intervention will be evaluated, and participants' questions will be addressed.
The primary outcome of the study will be the change in HbA1c levels from baseline to 6 months. Secondary outcomes will include changes in body weight, BMI, waist circumference, lipid profile, and carbohydrate counting knowledge level.
This study is expected to provide evidence on the effectiveness of a practical and applicable dietary intervention in preventing the progression from prediabetes to T2DM in primary care settings.
- Conditions
- Prediabetes
- Being tested
- Carbohydrate Couinting-Based Nutrition Education, Standard Care (No Structured Nutrition Education)
- Keywords
- Nutrition education, Basic carbohydrate counting, Self-management
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate Couinting-Based Nutrition EducationBehavioural
Participants assigned to the intervention group will receive a structured nutrition education program based on carbohydrate counting principles. The program will be delivered by a physician and will cover carbohydrate identification, portion estimation, meal planning, and practical application in daily dietary habits. The aim of the intervention is to improve glycemic control by increasing nutritional knowledge and promoting behavioral changes. Outcome measures will be evaluated at baseline, 3 months, and 6 months.
Standard Care (No Structured Nutrition Education)Behavioural
Participants in the control group will receive standard care without structured carbohydrate counting-based nutrition education.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care (No Structured Nutrition Education) | Active comparator | Participants in the control group will receive standard care without structured carbohydrate counting-based nutrition education. Receives: Behavioral: Standard Care (No Structured Nutrition Education) |
| Carbohydrate Counting-Based Nutrition Education | Experimental | Participants receive structured nutrition education based on carbohydrate counting, including dietary counseling and follow-up during the study period. Receives: Behavioral: Carbohydrate Couinting-Based Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in HbA1c level
The change in HbA1c levels from baseline to 6 months will be assessed to evaluate the effect of carbohydrate counting-based nutrition education.
Measured: from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start27 Apr 2026
- Primary completionJul 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to either an intervention group receiving nutrition education based on carbohydrate counting or a control group receiving standard care, in a parallel design.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamide Sahin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hamide Sahin, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525622
- Sponsor's protocol ID
- Marmara Univ IRB 09.2026.605
- Acronym
- CARB-PRED
- Status last verified
- May 2026
- First submitted
- 6 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Basic Carbohydrate Counting on HbA1c in Prediabetes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07525622
- Acronym / sponsor ID
- CARB-PRED / Marmara Univ IRB 09.2026.605
- Conditions
- Prediabetes
- Keywords
- Nutrition education, Basic carbohydrate counting, Self-management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hamide SahinUniversity, hospital or other
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 13 Apr 2026 (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.
Type 2 diabetes mellitus (T2DM) is a major global health problem with rapidly increasing prevalence. Prediabetes represents a high-risk state for developing T2DM and is often asymptomatic, delaying diagnosis and intervention. Early identification and effective lifestyle interventions are essential to prevent or delay the progression to diabetes. Primary care settings provide an important opportunity for screening and implementing preventive strategies.
Lifestyle modification, including dietary changes and physical activity, is the cornerstone of diabetes prevention. Carbohydrate counting is a medical nutrition therapy widely used in diabetes management and has been shown to improve glycemic control. However, there is limited evidence regarding its effectiveness in individuals with prediabetes.
This study aims to evaluate the effect of basic carbohydrate counting education on HbA1c levels in individuals with prediabetes in a primary care setting.
This randomized controlled trial will be conducted in the Family Medicine outpatient clinic of Marmara University Hospital. Individuals aged 18 years and older with HbA1c levels between 5.7% and 6.4% will be included. Participants will be randomized into intervention and control groups in a 2:1 ratio.
The control group will receive standard lifestyle recommendations, while the intervention group will receive additional structured basic carbohydrate counting education in three sessions. HbA1c levels will be measured at baseline,at third and at 6 months. Secondary outcomes include body weight, body mass index, waist circumference,lipid panel and carbohydarte counting knowledge scale The findings of this study are expected to contribute to the development of effective, scalable, and practical nutritional interventions for diabetes prevention in primary care
Detailed description
Type 2 diabetes mellitus (T2DM) is a major and rapidly growing global health problem. Prediabetes represents a high-risk state for progression to T2DM and provides a critical window for preventive interventions. Since prediabetes is often asymptomatic, early detection and effective lifestyle-based strategies are essential. Primary care settings offer an optimal environment for identifying high-risk individuals and implementing preventive interventions.
Lifestyle modification, particularly dietary interventions and physical activity, is the cornerstone of diabetes prevention. Medical nutrition therapy (MNT) has been shown to play a key role in improving glycemic outcomes. Basic carbohydrate counting (CC), as a component of MNT, is a practical and structured dietary approach aimed at increasing awareness of carbohydrate intake and improving glycemic control. However, evidence regarding its effectiveness in individuals with prediabetes remains limited.
This study aims to evaluate the effect of basic carbohydrate counting education on HbA1c levels in individuals with prediabetes in a primary care setting.
This study will be designed as a randomized controlled trial conducted at the Family Medicine outpatient clinic of Marmara University Hospital. Adults aged 18 years and older with HbA1c levels between 5.7% and 6.4% who meet the inclusion criteria and provide informed consent will be enrolled.
Participants will be randomized into intervention and control groups using a simple randomization method in a 2:1 ratio. All participants will receive standard lifestyle recommendations as part of usual care. Additionally, a booklet including information on healthy nutrition and basic carbohydrate counting, prepared based on current scientific literature, will be provided to all participants.
At baseline, all participants will complete a questionnaire assessing sociodemographic characteristics and diabetes-related factors. The "Nutrition and Basic Carbohydrate Counting Knowledge Scale" will be administered at baseline, 3 months, and 6 months. This scale consists of 20 items, including true/false statements and two fill-in-the-blank questions related to fasting and postprandial blood glucose.
Anthropometric measurements including body weight, body mass index (BMI), and waist circumference (WC) will be recorded at baseline, 3 months, and 6 months. Laboratory assessments including HbA1c, fasting blood glucose (FBG), and lipid profile will also be performed at the same time points.
Participants in the intervention group will receive structured basic carbohydrate counting education delivered in three sessions at one-week intervals, each lasting 30-45 minutes. The training program will be developed in collaboration with a dietitian. Participants in the intervention group will also be asked to complete 3-day dietary records before each training session.
Following the training sessions, participants in the intervention group will be followed up with monthly telephone calls. During these follow-ups, adherence to the intervention will be evaluated, and participants' questions will be addressed.
The primary outcome of the study will be the change in HbA1c levels from baseline to 6 months. Secondary outcomes will include changes in body weight, BMI, waist circumference, lipid profile, and carbohydrate counting knowledge level.
This study is expected to provide evidence on the effectiveness of a practical and applicable dietary intervention in preventing the progression from prediabetes to T2DM in primary care settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to either an intervention group receiving nutrition education based on carbohydrate counting or a control group receiving standard care, in a parallel design.
| Arm | Type | Receives |
|---|---|---|
| Standard Care (No Structured Nutrition Education) | Active comparator | Behavioral: Standard Care (No Structured Nutrition Education)Participants in the control group will receive standard care without structured carbohydrate counting-based nutrition education. |
| Carbohydrate Counting-Based Nutrition Education | Experimental | Behavioral: Carbohydrate Couinting-Based Nutrition EducationParticipants receive structured nutrition education based on carbohydrate counting, including dietary counseling and follow-up during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18 years and older
- Able to read and write Individuals with prediabetes who are not using or are unwilling to initiate oral antidiabetic drugs.
Key exclusion criteria (7 listed)
- Individuals with a diagnosis of diabetes mellitus
- Those who have previously received carbohydrate counting training or are currently applying carbohydrate counting
- Individuals with low daily carbohydrate intake (<100 g/day)
- Presence of uncontrolled medical conditions that may affect dietary intake, as determined by the investigator
- Pregnant or breastfeeding women, or those planning pregnancy during the study period
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 Couinting-Based Nutrition EducationParticipants assigned to the intervention group will receive a structured nutrition education program based on carbohydrate counting principles. The program will be delivered by a physician and will cover carbohydrate identification, portion estimation, meal planning, and practical application in daily dietary habits. The aim of the intervention is to improve glycemic control by increasing nutritional knowledge and promoting behavioral changes. Outcome measures will be evaluated at baseline, 3 months, and 6 months. | Behavioural | Carbohydrate Counting-Based Nutrition Education |
| Standard Care (No Structured Nutrition Education)Participants in the control group will receive standard care without structured carbohydrate counting-based nutrition education. | Behavioural | Standard Care (No Structured Nutrition Education) |
Primary outcome
The change in HbA1c level
Time frame: from baseline to 6 months
The change in HbA1c levels from baseline to 6 months will be assessed to evaluate the effect of carbohydrate counting-based nutrition education.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- 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.
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 Couinting-Based Nutrition Education in people with Prediabetes, run by Hamide Sahin 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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 12 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hamide Vural, MD (+905554907224, hamidesahin92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in HbA1c level (time frame: from baseline to 6 months). 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 May 2026.