BASIC CARBOHYDRATE COUNTING IN PREDIABETES

NCT07525622 | Not Yet Recruiting

• 1 other identifier: Marmara Univ IRB 09.2026.605
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Prediabetes, Nutrition Education,Carbohydrate Counting, HbA1c

Keywords

Prediabetes, basic carbohydrate counting, self-management

Outcome Measures

Primary Outcomes (1)

• The change in HbA1c level

  The change in HbA1c levels from baseline to 6 months will be assessed to evaluate the effect of carbohydrate counting-based nutrition education.

  from baseline to 6 months

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Behavioral: Control

intervention

EXPERIMENTAL

Participants receive structured nutrition education based on carbohydrate counting, including dietary counseling and follow-up during the study period.

Behavioral: Carbohydrate Couinting-Based Nutrition Education

Interventions

Control BEHAVIORAL

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

Control

Carbohydrate Couinting-Based Nutrition Education BEHAVIORAL

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.

intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years and older Able to read and write Individuals with prediabetes who are not using oral antidiabetic medications or who decline pharmacological treatment

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hamide Sahin: lead

Study Sites (1)

Marmara University Hospital

Istanbul, Pendik, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Hamide Vural, MD

CONTACT

+905554907224; hamidesahin92@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Family Medicine Specialist

Model Details: Participants will be assigned to either an intervention group receiving nutrition education based on carbohydrate counting or a control group receiving standard care, in a parallel design.

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)