Actively Recruiting
The Effect of Basic Carbohydrate Counting on HbA1c in Prediabetes: A Randomized Controlled Trial
Led by Hamide Sahin · Updated on 2026-05-12
120
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Type 2 diabetes mellitus is a growing global health issue, and prediabetes is a high-risk condition that often has no symptoms. Early detection and lifestyle changes are important to prevent or delay diabetes development. This study evaluates the effect of basic carbohydrate counting education on blood sugar control (HbA1c levels) in adults with prediabetes in a primary care setting. Participants aged 18 and older with HbA1c levels between 5.7% and 6.4% will be randomly assigned to two groups. One group receives standard lifestyle advice, while the other also gets structured carbohydrate counting education in three sessions. Education sessions are held weekly and include teaching on identifying carbohydrates, portion sizes, and meal planning. The intervention group will also complete dietary records and receive monthly follow-up calls. Participants will undergo assessments at the start, 3 months, and 6 months, including blood tests for HbA1c, fasting glucose, and lipid levels, as well as measurements of weight, body mass index, and waist size. Knowledge about carbohydrate counting will be tested using a special questionnaire. Researchers will track changes in blood sugar control and other health measures over 6 months. The study aims to provide practical dietary approaches to help prevent diabetes progression in primary care.
CONDITIONS
Brief Title
Basic Carbohydrate Counting in Prediabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Able to read and write
- Individuals with prediabetes who are not using or unwilling to start oral antidiabetic drugs
You will not qualify if you...
- Diagnosis of diabetes mellitus
- Previous or current use of carbohydrate counting
- Daily carbohydrate intake less than 100 grams
- Uncontrolled medical conditions affecting diet
- Pregnant, breastfeeding, or planning pregnancy during the study
- Participation in another clinical study
- Unable or unwilling to provide informed consent or comply with procedures
- Cognitive or communication difficulties such as hearing, understanding, or speaking problems
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants in the intervention group receive structured nutrition education based on carbohydrate counting in three sessions at one-week intervals. All participants complete questionnaires and have anthropometric and laboratory assessments at baseline, 3 months, and 6 months.
3 in-person visits at baseline, 3 months, and 6 months; 3 weekly education sessions for intervention group; monthly telephone calls for intervention group
Trial Site Locations
Total: 1 location
1
Marmara University Hospital
Istanbul, Pendik, Turkey (Türkiye), 34000
Actively Recruiting
Research Team
H
Hamide Vural, MD
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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