Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
58 participants
INTERVENTIONAL
2022-08-01
2024-12-30
Brief Summary
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Detailed Description
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A questionnaire form containing sociodemographic information was completed by face-to-face interview method. In addition, biochemical (HbA1c, fasting plasma glucose (FPG), C peptide, total cholesterol, HDL, LDL, triglyceride, estimated glomerular filtration rate) and anthropometric and body composition (weight-height, BMI, fat mass, fat ratio, muscle mass, lean tissue mass, waist circumference), hand grip strength and blood pressure measurements of the patients were taken at the beginning, 12th week and 24th week of the study.
In addition, a 24-hour retrospective food consumption record was applied to evaluate the energy and nutrient intakes. The calculation of the energy, macro and micro-nutrient intakes of the participants was carried out using the Turkish Nutrition Database Ebispro for Windows program (version 7.2)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Training Group
The training group received advanced carbohydrate counting training in addition to standard medical and medical nutrition therapy.
Carbohydrate Counting Training
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.
Control Group
The control group continued standard medical and medical nutrition therapy only.
No interventions assigned to this group
Interventions
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Carbohydrate Counting Training
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Medipol University
OTHER
Responsible Party
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Funda GARGACI TUNCER
Principal Investigator
Principal Investigators
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Indrani KALKAN, Assoc. Prof.
Role: STUDY_DIRECTOR
Medipol University
Locations
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Uskudar Diabetes Polyclinic of the Fatih Sultan Mehmet Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Document Type: Statistical Analysis Plan
Other Identifiers
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IMU- SBE-FGT-01
Identifier Type: -
Identifier Source: org_study_id
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