Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07525622

Basic Carbohydrate Counting in Prediabetes

Led by Hamide Sahin · Updated on 2026-05-12

120

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Basic Carbohydrate Counting in Prediabetes

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years and older
  • Able to read and write
  • Individuals with prediabetes who are not using or are unwilling to start oral antidiabetic drugs
Not Eligible

You will not qualify if you...

  • Diagnosis of diabetes mellitus
  • Previous or current carbohydrate counting training or use
  • Low daily carbohydrate intake (less than 100 grams per day)
  • Uncontrolled medical conditions affecting diet
  • Pregnant or breastfeeding women, or planning pregnancy during the study
  • Participation in another clinical trial
  • Inability or unwillingness to provide informed consent or follow study procedures
  • Cognitive or communication difficulties such as hearing, understanding, or speaking problems

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Marmara University Hospital

Istanbul, Pendik, Turkey (Türkiye), 34000

Actively Recruiting

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Research Team

H

Hamide Vural, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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