Carbohydrate Counting Training in Type 2 Diabetes

NCT07016958 | Completed DMC

• 1 other identifier: IMU- SBE-FGT-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the efficacy of carbohydrate counting in individuals with type 2 diabetes receiving intensive insulin therapy. In addition, the sarcopenia status in this patient group and the effect of carbohydrate counting on sarcopenia were also evaluated.

Conditions

Diabetes Mellitus Type 2; Sarcopenia

Keywords

Diabetes; carbohydrate; glycemic control; insulin; sarcopenia

Outcome Measures

Primary Outcomes (5)

• HbA1c (%)

  HbA1c levels of the participants were performed in the Biochemistry Laboratory of Fatih Sultan Mehmet Training and Research Hospital. The individuals participating in the study were asked to give blood in the morning after 10-12 hours of fasting after dinner. HbA1c levels were measured by high-performance liquid chromatography (HPLC) method. The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.

  Baseline, week 12 and week 24

• Plasma Glucose Levels

  Plasma glucose levels of the participants were performed in the Biochemistry Laboratory of Fatih Sultan Mehmet Training and Research Hospital. The individuals participating in the study were asked to give blood in the morning after 10-12 hours of fasting after dinner. Plasma glucose levels were analyzed by hexokinase method in colorimetric-spectrophotometric Aeroset (Roche Hitachi cobas 6000) autoanalyzer. The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.

  Baseline, week 12 and week 24

• Muscle Strength

  It was used for the evaluation of sarcopenia. The participants' hand grip strength was measured three times with a digital hand dynamometer (CAMRY-EH101, USA) and the mean value in kg was calculated. The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.

  Baseline, week 12, week 24

• Skeletal muscle mass

  It was used for the evaluation of sarcopenia. Skeletal muscle mass data obtained from the BIA measurement results and skeletal muscle according to the height obtained from this data were calculated by dividing the skeletal muscle mass by the square of the height.The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.

  Baseline, week 12, week 24

• Physical performance

  It was used for the evaluation of sarcopenia. In the timed walk-up test, the patient is asked to get up from the chair, walk at a normal walking speed on a flat surface of 3 meters, turn around, walk back and sit back in the chair. The time between the patient getting up from the chair, walking and sitting down again is recorded and the patient's dynamic balance during walking is also evaluated. The statistical analysis of the data obtained from the study was evaluated using the IBM SPSS Statistics (version 22.0) package program.

  Baseline, week 12 and week 24

Secondary Outcomes (15)

• Blood lipid levels

  Baseline, week 12 and week 24

• Hypoglicemia Period

  Baseline, week 12 and week 24

• Total Insulin Dose

  Baseline, week 12 and week 24

• Daily Prandial Insulin

  Baseline, week 12 and week 24

• Daily Basal Insulin

  Baseline, week 12 and week 24

Study Arms (2)

Training Group

EXPERIMENTAL

The training group received advanced carbohydrate counting training in addition to standard medical and medical nutrition therapy.

Behavioral: Carbohydrate Counting Training

Control Group

NO INTERVENTION

The control group continued standard medical and medical nutrition therapy only.

Interventions

Carbohydrate Counting Training BEHAVIORAL

Advanced Carbohydrate Counting Training is a meal planning training where individuals can calculate the amount of carbohydrates in foods based on their portion sizes, and the insulin doses they need to take based on their plasma glucose levels and the amount of carbohydrates they consume.

Training Group

Eligibility Criteria

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

You may qualify if:

• A history of type 2 diabetes mellitus
• Using insulin for more than one year
• Being over 18 years old
• Receiving basal and bolus insulin treatment
• Not having received carbohydrate counting training before
• Not receiving treatment with sulfanylurea drugs from oral anti-diabetics.

You may not qualify if:

• Being pregnant or breastfeeding or planning a pregnancy during the study period,
• Discontinuing insulin treatment during the study period
• Having active proliferative retinopathy, severe nephropathy, severe or newly diagnosed cardiac disease within 6 months or stage III-IV heart failure,
• Having dementia or psychosis and cognitive impairment,
• Receiving glucocorticoid treatment, being fed enterally or parenterally and receiving nutrition treatment due to another/concomitant disease, having end-stage renal or hepatic/ renal disease (other than proteinuria)
• Having liver disease/microangiopathy diseases
• Having clinical cancer, chronic respiratory disease or amputations,
• Having any disease or condition that would prevent completion of the study.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Uskudar Diabetes Polyclinic of the Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34672, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Sarcopenia; Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hyperinsulinism

Study Officials

• Indrani KALKAN, Assoc. Prof.

  Medipol University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There are two groups: training and control group.

Study Record Dates

• First Submitted: May 31, 2025
• First Posted: June 12, 2025
• Study Start: August 1, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)