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Recruiting Not applicable

Basic Carbohydrate Counting in Prediabetes

NCT07525622 · tracked via the Priya Life Science Turkey tracker
Sponsor
Hamide Sahin
Phase
Not applicable
Started
2026-04-27
Last updated
2026-05-12

Condition(s) studied

Prediabetes

Investigational drug(s) / intervention(s)

Carbohydrate Couinting-Based Nutrition EducationStandard Care (No Structured Nutrition Education)

Carbohydrate Couinting-Based Nutrition Education: 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): Participants in the control group will receive standard care without structured carbohydrate counting-based nutrition education.

Study 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. 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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)

Primary outcome measure(s)

  • The change in HbA1c level — 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.

Trial sites (1)

FacilityCityRegionStatus
Marmara University Hospital Istanbul Pendik Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07525622 on ClinicalTrials.gov ↗ ← All trials in Turkey