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Basic Carbohydrate Counting in Prediabetes

NCT07525622 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-12

No results posted yet for this 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

Conditions

Interventions

BEHAVIORAL

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.

BEHAVIORAL

Standard Care (No Structured Nutrition Education)

Participants in the control group will receive standard care without structured carbohydrate counting-based nutrition education.

Sponsors & Collaborators

  • Hamide Sahin

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-27
Primary Completion
2026-07-31
Completion
2026-11-30

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07525622 on ClinicalTrials.gov