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The Effect of Basic Carbohydrate Counting on HbA1c in Prediabetes: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Turkey
Marmara University Hospital
RECRUITING
Istanbul
Contact Information
Primary
Hamide Vural, MD
hamidesahin92@gmail.com
+905554907224
Time Frame
Start Date: 2026-04-27
Estimated Completion Date: 2026-11
Participants
Target number of participants: 120
Treatments
Active_comparator: Standard Care (No Structured Nutrition Education)
Participants in the control group will receive standard care without structured carbohydrate counting-based nutrition education.
Experimental: Carbohydrate Counting-Based Nutrition Education
Participants receive structured nutrition education based on carbohydrate counting, including dietary counseling and follow-up during the study period.
Related Therapeutic Areas
Sponsors
Leads: Hamide Sahin

This content was sourced from clinicaltrials.gov

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