Basic Carbohydrate Counting in Prediabetes

Recruiting now · Not applicable

Conditions studied: Prediabetes

In brief

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

Key facts

Study ID

NCT07525622

Run by

Hamide Sahin

People needed

120

Starts

2026-04-27

Expected to finish

2026-11-01

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Marmara University Hospital — Istanbul, Pendik, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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