Basic carbohydrate counting for adults with prediabetes
The Effect of Basic Carbohydrate Counting on HbA1c in Prediabetes: A Randomized Controlled Trial
This program will test whether basic carbohydrate counting education helps adults with prediabetes lower their HbA1c.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Marmara University Academic / other |
| Locations | 1 site (Istanbul, Pendik) |
| Trial ID | NCT07525622 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial conducted in a primary care outpatient clinic at Marmara University Hospital enrolling adults with HbA1c 5.7%–6.4%. Participants are randomized to receive structured basic carbohydrate-counting nutrition education or standard care without structured nutrition education. The main outcome is change in HbA1c following the intervention, with other self-management and dietary measures collected as part of routine follow-up. The trial targets feasible, clinic-deliverable education to see if a simple, structured nutrition approach can alter short-term glycemic risk markers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with prediabetes (HbA1c 5.7%–6.4%), able to read and write, not currently using or unwilling to start oral antidiabetic drugs, and who have not previously learned carbohydrate counting.
Not a fit: People with diagnosed diabetes, those already using carbohydrate counting, individuals with very low daily carbohydrate intake (<100 g/day), pregnant or breastfeeding women, or those with uncontrolled medical conditions or cognitive/communication barriers are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the intervention could offer a simple, clinic-based education method to lower HbA1c and help delay or prevent progression to type 2 diabetes.
How similar studies have performed: Carbohydrate counting is an established tool that improves glycemic control in people with diabetes, but there is limited direct evidence demonstrating its benefit specifically in prediabetes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 this trial is running
Istanbul, Pendik
- Marmara University Hospital — Istanbul, Pendik, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Hamide Vural, MD
- Email: hamidesahin92@gmail.com
- Phone: +905554907224
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.